ABSTRACT: Research is the process of discovering new knowledge. This knowledge can be either the development of new concepts or advancement of existing knowledge and theories, leading to a new understanding that was not previously known. The current focus of homoeopathic research is on the evidence-based studies based on universally acknowledged parameters, with special emphasis on documentation. There are various domains in research and in field of homoeopathy, we work on many of them in order to justify it as an evidenced-based science. Here, we are stating common research domains in Homoeopathy.
KEYWORDS: Research, homoeopathy, research domains, drug standardisation, drug proving, clinical verification, clinical research, fundamental research, literary research, community health research
ABBREVIATIONS: thin layer chromatography (TLC), good manufacturing practise (GMP), ultraviolet (UV)
Homoeopathy is a therapeutic science of symptom similarity based on the axiom ‘like cures like’. It is gaining universal popularity because of its efficacy in various clinical conditions, affordability, absence of adverse drug reactions and easier applicability. It remains a popular choice of treatment worldwide, with more and more people choosing it for holistic and individualised treatment. The homoeopathic research is gaining momentum, where the responsibility lies in undertaking quality research. Several research organisations worldwide are focusing on building the evidence base for Homoeopathy. There are many research domains in homoeopathy which are discussed in this article and researches can be done in such domains in order to make homoeopathy an evidence-based science.
- Drug standardisation studies
The process of evaluation of the quality and purity of crude drugs by means of various parameters like morphological, microscopical, physical, chemical and biological observations is called drug standardization . Standardization and quality control of homeopathic drugs is very challenging and is done according to uniform standards as mentioned in the pharmacopoeia.
The problem of quality control with homoeopathic potencies serves one of the greatest challenges. As mother tinctures are derived from complex natural resources, there is a need of systematic evaluation of chemical markers which correlate with the proposed biological activities of mother tinctures . In India, The Drug and Cosmetics Act 1940 controls quality of homoeopathic medicines . Good manufacturing practise (GMP) must be in force to assure and assess the quality of homoeopathic preparations . The pharmacopoeia indicates in the monograph of each drug, details for identification and collection, the part to be used, the method of preparation, assessment of purity and limits of impurity. It is essential that these instructions be strictly followed to obtain mother tinctures of desired standards .
Drug standardisation studies encompasses a comprehensive evaluation of the homoeopathic drugs in respect of their physico-chemical, pharmacognostical and pharmacological profiles in order to study the various qualitative and quantitative characteristics of drugs .
- Physico-chemical studies
The physicochemical parameters of the raw drug and prepared mother tincture include moisture content, ash value, extractive value, presence of active constituents in raw drug and organoleptic characteristics, carrying out specific tests and TLC, UV spectrophotometry of the mother tincture. These can be used as a bench mark standard against any commercial sample.
Ash values are used to determine quality and purity of crude drug. The water-soluble ash is used to estimate the amount of inorganic compound present in drugs. The acid insoluble ash consists mainly silica and indicates contamination with earthy material. Moisture content of drugs should be at minimal level to discourage the growth of bacteria, yeast or fungi during storage. Estimation of extractive values determines the amount of the active constituents in a given amount of plant material when extracted with a particular solvent. The extractions of any crude drug with a particular solvent yield a solution containing different phytoconstituents [7,8].
- Gupta HC, Subramanian P, Padma RP, Raj J, Sharma SK. Standardisation of Homoeopathic drug – Aquilegia vulgaris L. IJRH.2011;5(2):15-19.
- Subramanian P, Padma RP, Reddy, Gupta HC. Standardisation of homoeopathic drug – Syzygium jambos (L.) Alston. IJRH.2011;5(3):15-19.
1.2 Pharmacognostic studies
The pharmacognostical studies of raw drug plant material includes study of the gross morphology of the raw drug, its macroscopical and microscopical characteristics and after suitable processing, enumeration of characteristic structures of cells, tissues and organs under the microscope and determining their essential biostatistical dimensions. Organoleptic evaluation can be done by means of sense organs, which provide the simplest as well as quickest means to establish the identity and purity to ensure quality of a particular drug. Organoleptic characters such as shape, size, colour, odour, taste and fracture of stem bark, leaf structure like margin, apex, base, surface, venation and inflorescence, etc. are evaluated.
Macroscopic study: The macroscopic study is the morphological description of the plant parts which are seen by naked eye or magnifying lens.
Microscopic study: The microscopic study is the anatomical study which is done by taking appropriate section of the plant parts under study. Each distinguishing character can be noted down .
- Patel S, Biswas B, Nagaraju M, Jhansi S, Arya R, Sundaram E. Pharmacognostic studies of Polygala senega L. Root– a homoeopathic drug. IJRH. 2018;12(1):4-10.
- Subramanian P, Pogaku PR, Penthala S,
Narayana PS. Pharmacognostic and physicochemical
standardization of homoeopathic drug: Rumex crispus L. IJRH.
1.3 Pharmacological studies
The pharmacological spectrum of a drug is ascertained through experimental trials on laboratory animals under standard laboratory conditions which include preliminary estimation of dosage, evaluation of efficacy and safety and also the mode of action of homoeopathic drugs .
Examples of pharmacological studies:
- Sundaram EN, Singh KP, Reddy PK, Nair KRJ, Khurana A, Singh H et al. An investigation to evaluate the analgesic and central nervous system depressant activities of Solanum nigrum (Linn.) In Homoeopathic potencies in experimental animal models. IJRH. 2015; 9(1): 12-19.
- Sundaram EN, Singh KP, Reddy PK, Kumar S, Nair KRJ, Khurana A et al. Preliminary study to evaluate analgesic and behavioural effects of Lycopodium clavatum in experimental animals. IJRH.2013; 7(4): 168-175.
2. Drug proving
Also known as Homoeopathic Pathogenetic Trial, these are similar to phase I clinical research trials in conventional medicine but with different and added objectives. Phase I clinical trial is designed to reduce the risk of serious (drug) toxicity and avoid confounding pharmacologic and adverse effects; whereas in Homoeopathy, in subphysiological/ultramolecular doses of potentially toxic or pathogenic substances are commonly used on healthy human beings to deduce characteristic symptoms of drugs for their clinical use in accordance with homoeopathic principles .
The focus of research in this field has been to introduce drugs of indigenous systems into Homoeopathy and to reprove partially proved drugs. Homoeopathic medicines are proved on healthy human volunteers, including controls, from both sexes and age group between 18-60 years . The methodology of drug proving has changed considerably since the times of Hahnemann. Proving guidelines have been developed by various international bodies [12-14] on the basis of which proving protocols for individual drugs are developed by researchers for individual studies . In addition to exposing the toxic effects of the drug, homoeopathic drug proving serves as a key source of information for the homeopathic materia medica . Hahnemann did not use blinding in the proving studies. However, over the years, blinding of provers was introduced and blinding technique was a routine procedure. As randomized control techniques developed, homoeopathic researchers adopted blinding procedures for drug proving .
- Shaw TR, Singh V, Siddiqui VA, Rajpal, Singh VK, Singh H et al. POTHOS FOETIDUS – A multicentric double blind Homoeopathic Pathogenetic Trial. IJRH.2009; 3(1): 18-22.
- Rakshit G, Vichitra AK, Chandra PK, Rajpal, Singh VK, Choudhury SK. Ocimum sanctum- A multicentric double blind homoeopathic pathogenetic trial. IJRH.2014; 8(1): 9-18.
3. Clinical verification
The verification of drug proving symptoms has been an essential aspect in clinical practice since Hahnemann discovered Homoeopathy. Here a drug is given to the sick, according to the symptoms, it had produced on the healthy (proving) human beings and the cures made were the verifications. Only by clinical verification, a proving symptom will prove its validity as homoeopathic symptom and cement its value for the practicing physicians . Verification of homeopathic symptoms has so far been a neglected field. What is the use of efficacy research if the instruments of the method have serious flaws? The most serious flaw of the homeopathic repertory is that entries of medicines in a symptom-rubric are based on absolute occurrence of the symptom in the cured population, not on prevalence. This way, frequently used medicines are over-rated, especially regarding frequently used symptoms. Bayesian theory shows that the prevalence of the symptom is the only correct criterion. A symptom is an indication for a specific medicine only if the prevalence of that symptom is higher in the population cured by that medicine than in the rest-population .
Purpose of clinical verification is data collection for clinical verification of symptoms from homoeopathic proving and collection of clinical symptoms not derived from homoeopathic pathogenetic trials . The importance of clinical verification of proving symptoms is historical and even more importantly, relevant to validate ‘modern’ homoeopathic practice. It is the study of the link between pathogenetic symptoms and curing of patients presenting these symptoms. An unconfirmed proving symptom that never was verified by clinical data cannot yet be considered as useful for homoeopathic practice .
- Manchanda RK, Chakraborty P, Singh P, Pradhan PK, Prasad VG, Singh O et al. A multicenter, observational, homoeopathic clinical verification study of Cynodon dactylon revealing symptom prevalence in a cohort of 340 patients. IJRH.2016;10(4): 225-237.
- Manchanda RK, Chakraborty P, Das KC,
Rai MK, Singh Ojit, Pradhan PK et al. Symptom prevalence in a cohort of 147
patients improved with the homoeopathic medicine Ocimum canum: A multicenter,
open, observational, clinical verification study. IJRH.2016; 10(4): 238-248.
Clinical research involves the study of the clinical efficacy of materials and methods that play a significant role in the prevention and cure of various health disorders. Clinical research studies aim towards the genesis and implementation of better means of safe and effective medical practices, diagnostic techniques, devices, medication, diagnostic tools and regimens that are essential for proper healthcare management. It also involves the clinical trial of drugs, diagnostic techniques and other therapeutic strategies, before they are prescribed for the patients in real time conditions . Clinical research also provides valuable information about the benefits and safety of existing therapies which gives doctors and patients reliable information when choosing treatments .
The initiation of clinical research study requires certain steps: literature review, protocol development, technical/administrative approval from experts, ethical clearance, selection of study design, and choosing the correct outcome measures. The overall aim should be to add more evidence to the existing pool by systematic reviews, randomized controlled trials (RCTs), observational studies, high-quality case reporting, etc., as the case may be. The systematic reviews and meta-analyses are positioned on top of the hierarchy of evidence-based research. They answer a defined research question by collecting and summarizing all empirical evidences that fit pre-specified eligibility criteria. The RCTs are widely accepted as the most powerful research method for evaluating health technologies . Although numerous study designs can address these goals, clinical trials (and specifically RCTs) remain the benchmark for comparing disease interventions .
Clinical research in Homoeopathy helps in generating, validating and consolidating scientific evidences (in terms of safety, efficacy and effectiveness) of homoeopathic medications, procedures and treatment regimes. These researches may be useful in prevention, treatment of various diseases, decision making for stake holders and thus help in improving clinical care. The aim is to carry out evidence-based trials based on modern scientific parameters (double blinding; objective assessment criteria, statistical analysis, etc.) without conflicting with the doctrines of Homoeopathy .
- Ghosh MS, Bawaskar R, Taneja D, Kashyap S.An open label pilot study to explore usefulness of Homoeopathic treatment in nonerosive gastroesophageal reflux disease. Indian Journal of Research in Homoeopathy.2016; 10(3): 188-198.
- Nayak C, Singh V, Gupta J, Ali MS, Pal R, Arya MD et al. Homoeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis: A multicentre prospective randomized exploratory clinical study. IJRH.2012; 6(4):16-23.
- Khurana A, Mittal R, Rath P, Moorthy K, Taneja D, Singh U et al. Ferrum phosphoricum 3X and Ferrum metallicum 3X in the treatment of iron deficiency anaemia in children: Randomized parallel arm study. IJRH.2020; 14(3): 171-178.
- Nair KRJ, Gopinadhan S, Kurup TNS, Kumar BSJR, Aggarwal A, Varanasi R. Homoeopathic Genus Epidemicus ‘Bryonia alba’ as a prophylactic during an outbreak of Chikungunya in India: A cluster -randomised, double -blind, placebo- controlled trial. IJRH.2014 ;8(3): 160-165.
- Basic and fundamental research
Fundamental research does not usually generate findings that have immediate applications in a practical level. Fundamental research is driven by curiosity and the desire to expand knowledge in specific research area. This type of research makes a specific contribution to the academic body of knowledge in the research area. Fundamental studies tend to make generalizations about the phenomenon, and the philosophy of this type of studies can be explained as ‘gathering knowledge for the sake of knowledge’ . Basic research is performed without thought of practical ends. It results in general knowledge and understanding of nature and its laws. The general knowledge provides the means of answering a large number of important practical problems, though it may not give a complete specific answer to any one of them. The function of applied research is to provide such complete answers. Basic research leads to new knowledge . Fundamental researches mainly aim to answer the questions of why, what or how and they tend to contribute the pool of fundamental knowledge in the research area .
Homoeopathy has been able to spark a few scientific minds to explore the plausibility of action and nature of high dilutions in vitro and in vivo experimentation using valid models. The mechanism of action of homoeopathic drugs has been the subject of basic research experiments carried out by biologists, physicists, and chemists. The fundamental research currently is aimed at on effects of homoeopathic preparations in bioassays as well as research on physico-chemical effects of the preparation process (potentization). To improve our knowledge of Homoeopathy (Similia principle and specific preparation of medicines) and to increase the understanding of the working mechanism of its medicines, fundamental research is a prerequisite .
a) Prajapati P, Sharma M, Gupta P, Kumar M, Dwivedi B, Arya BS. Evaluation
of antifungal activity of different homoeopathic mother tinctures against
Candida albicans.IJRH.2017; 11(4): 237-243.
b) Khuda-Bukshsh AR. Search for a molecular mechanism of action of the
potentised homeopathic drugs in living organisms. Int J High Dilution Res.
- Theoretical research
Theoretical research is a logical exploration of a system of beliefs and assumptions. Formal theory and mathematical exploration are the basis for most of theoretical research. This is primarily due to the fact that theoretical work is in logical space where theories must be modelled and represented in some language. Mathematics is the perfect language suited to defining and exploring possibilities. As such, a lot of work involves formal proofs and internal validity . Theoretical research is one where the author, hopefully ethically, surveys data via a sustained discussion that allows the reader to deductively or inductively come to a conclusion. In the empirical research, articles are more compartmentalized in order to demonstrate to the readers what was found, whereas theoretical research arguments are sustained to invite the readers into the argument .
- Sekonyela TV. Scientific Basis of Homeopathic Medicine: A Hypothesis to Establish the Scientific Basis of Homeopathy. J Tradi Med Clin Natur. 2016; 5:185.
- Lucadou W. Homeopathy and the Action of Meaning: A Theoretical Approach. Journal of Scientifi c Exploration. 2019;33(2):213–254.
- Literary research
Literary research is the new way to interpret the information of what is already existing in literature and discuss it. You can find an article about the work and disagree with it or you can find the article that you agree with and expand the author’s opinion or you can come up with completely new idea. You can argue at some point or say something specific like an argument on thesis main idea. Book report can also be written in which someone can summarize a book. In literary research, it’s not the idea of other people that matters as much as your own interpretation of the text you are reading.
The Central Council for Research in Homoeopathy, under the literary research activity, brings out quality publication in the form of books, monographs, handouts etc. Prior to the era when computers and software repertories became widespread, Council updated different chapters of Kent’s repertory from Boericke’s repertory to form a comprehensive document. Chapters on ‘Mouth’, ’Eye & vision’, ‘Ear & Hearing’, Larynx& Trachea, respiration, cough, expectoration and chest’, etc. were completed in this period. Updating ongoing homoeopathic literature on the basis of present-day findings is an ongoing literary research activity of the Council .
- Koley M, Saha S, Das KD, Roy S, Goenka R, Chowdhury PR et al. Prospective Evaluation of Few Homeopathic Rubrics of Kent’s Repertory from Bayesian Perspective. J Evid Based Complementary Altern Med.2016 Oct;21(4):277-281.
- Schmidt JM. 200 years Organon of Medicine – A comparative review of its six editions (1810-1842). Homeopathy. 2010 Oct;99(4):271-277.
- Community health research
The use of community-based health research is to address and eliminate health disparities. The benefit of community-based research is the ability to reach people where they are and identify the root cause of disease. “The community-level approach to disease prevention is based not on a medical model but on a public health model. That is, it seeks to change not simply individuals or groups of individuals but the distribution of disease in the population as a whole”. Community-based health research guides public health workers who are engaged in improving the health of populations, just as traditional clinical research guides the actions of clinicians in caring for individual patients .
Homoeopathy is practised in many countries as a part of the public health system. The health authorities of each country/region have the power to identify priority areas for research in Homoeopathy. The prioritization depends upon many factors, some of which may be resources, prevalent diseases and unanswered questions to medical problems which otherwise cannot be dealt with mainstream medical practices. There is a need to identify global as well as local priority areas for research in Homoeopathy, especially for public health use. This may be notified to health priority areas for research in Homoeopathy .
- Manchanda RK, Oberai P, Roja V, Singh S, Singh N, Khan T et al. Evaluation of homoeopathic medicines as add‑on to institutional management protocol in Acute Encephalitis Syndrome: An exploratory observational comparative study. Indian Journal of Research in Homoeopathy.2015; Vol. 9(1):34-41.
- Kumar A, Mishra N. Effect of Homoeopathic treatment on filariasis-A single blind 69-months follow-up study in an endemic village in Odisha. British Homoeopathic Journal. Oct 1994; Vol. 83 (4): 216-219.
- Khandelwal KR. Practical Pharmacognosy. 19th ed. Pune: Nirali Prakashan; 2008.
- Jadhav H, Chaudhari G, Patil D, Jadhav R, Reddy N, Shirkhedkar A et al. Standardization of homeopathic mother tincture of Toxicodendron pubescens and correlation of its flavonoid markers with the biological activity. Homeopathy. 2016 Feb;105(1):48-54.
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Research Officer (Homoeopathy)/ Scientist-1, Homoeopathic Drug Research Institute, under Central Council for Research in Homoeopathy, Lucknow-226010, U.P, India.
Former Director General, Central Council for Research in Homoeopathy and former President, Homoeopathy University, Jaipur-302029, Rajasthan, India.