A Single-Blind, Comparative Study To Evaluate The Efficacy Of Nyctanthes Arbortristis 30C Prepared From Leaves To Nyctanthes Arbortristis 30C Prepared From Seeds In Cases Of Tinea Corporis - homeopathy360

A Single-Blind, Comparative Study To Evaluate The Efficacy Of Nyctanthes Arbortristis 30C Prepared From Leaves To Nyctanthes Arbortristis 30C Prepared From Seeds In Cases Of Tinea Corporis

Abstract
Background: Ringworm is highly infectious skin infection that causes a ring like red rash on the skin. It is more prevalent in India as most of the states have humid environment where dermatophytes find easy to thrive and multiply. Antifungal properties are found in leaves and seeds of Nyctanthes Arbortristis.
Materials and Methods: 50 diagnosed patients of either sex with T. corporis infection were allotted in 2 arms, group A (leaf based formulation) and group B (seed based formulation). Change in Mean Grading Score (MGS) from baseline to end of study (after 3 months) for each group was the primary endpoint. Other endpoints studied were, the percentage of patients who showed recovery, improvement and those that did not improve in both groups. Individual symptom and signs scores were also evaluated in comparison to baseline as well as between groups.
Results: At end of study, the mean value of MGS in group A was improved from 6.7 ± 1.2 to 3.9 ± 1.5 (P < 0.0001), whereas, in Group B, the mean MGS was improved from 6.4 ± 0.8 to 3.8 ± 1.4 (p<0.0001). In Group A, 32% of patients were found to be recovered and 41 % of the patients showed improvement . In Group B, 21% of patients were found to be recovered and 58% of patients were improved compared to baseline.
Conclusion: There is a significant improvement in Tinea corporis infections in patients receiving medicine prepared from leaves or seeds of Nyctanthes Arbortristis.
Keywords
Mean grading score, Tinea corporis, Nyctanthes Arbortristis
Introduction
Incidence of ringworm is estimated to be approximately 20% of Indian population. It is very contagious and ring-like red rash on the skin. Recurrence rate is very high. Nyctanthes possess many chemical constituents and of which many have anti-fungal properties . Medicine prepared from leaves of Nyctanthes arbortristis which had effect on symptomatic relief in the patient of ringworm recorded in few studies. A new formulation prepared from the seed of the same plant also possess antifungal properties. Due to recurrence and prevalence of disease, it was necessary to find a solution for ringworm.
Objective
To study the efficacy of Nyctanthes Arbortristis 30C either prepared from leaves or Nyctanthes Arbortristis 30C prepared from seeds for symptomatic relief and reduction in lesion score in patients of Tinea corporis.
Materials and Methods
Study Design: A single centre, open labelled study conducted at Shri B. A. Dangar Homoeopathic Medical college and Hospital, Rajkot, Gujrat. 50 participants were with Tinea corporis of either sexes. Study was conducted From July 2018 to May 2019. The informed consent had been obtained from all the patients. Follow up of each participant was on every 15 days till 3 months and when required as per patient need. Patient were randomized to receive either Medicine A or Medicine B orally. Patient were stratified as per sex.
Patients of either sex of age group 21 to 45 years suffering from Tinea corporis with other disorders like DM, HTN, IHD, thyroid disorder are also included in the study. Asthmatics who are only on inhalers were also included. Patients under homoeopathic treatment for last 2 months were excluded. Patients with active acute diseases like Malaria, Typhoid, Dengue, Hepatitis were also excluded from study.
Patient whose total lesion score of minimum 5 grades or more were included in study. Patient on psychiatric drug, immunocompromised patients, Patients on antifungal tablets before two weeks or who is using local application for 2 weeks, Patients on oral steroids were excluded from the study. Any episodes of altered health involving hospitalization in last 3 months, current uncontrolled DM, Female with confirmed pregnancy were also excluded from the study.
The lesion score was calculated by adding the grades of total symptoms present in a participant. Each symptom (itching, erythema, vesicles, scaling and discolouration) were graded in 4 grades from 0 to 3.
Intervention: 24 participants with tinea corporis had been given medicine A and 26 participants with tinea corporis has been given B. Nyctanthes Arbortristis 30C from leaves (MED A) and Nyctanthes Arbortristis 30C from seeds (MED B) had been administered orally only on an empty stomach. Each case had been given a single dose of selected medicine either Medicine A or Medicine B in powder form as the stat dose on first visit and in follow up same medicine in powder form as per the physician directions. Sac Lac 30C was also given in powder form and each dose packed in powder form labelled as morning, evening and night given for 15 days on first visit. In subsequent visit, Sac Lac 30C as per the physician directions. At each follow up, the patients were evaluated in details for tinea in detailed including general wellbeing and any new complaints. The subject participating in the study were asked to report on the scheduled date that is after every 15 days from the date of first consultation. If the patient did not report on fixed date, efforts were made to contact her/him. Whenever necessary Med. A or Med. B can be repeated as per the participant’s complaints.
Outcome Assessment Criteria:
A. The primary outcome was change in Mean Grading score at the end of 3 months compared to baseline. Mean grading score had been calculated using the grades of Itching, erythema, vesicles, scaling and discolouration. Each of these parameters were graded on a 4-point scale (0-3). After grading the efficacy parameters during the first visit the total added scores for all the 5 efficacy parameters provided the “Mean Grading Score”(MGS). A marked clinical response was considered to be reduction of 4 or more in the clinical score to a final value less than 4 or final score of 0 in MGS.
B. Proportion of patients who recovered, improved and not improved at the end of 3 months observation period. Participants were considered to be recovered if there was a reduction of 4 or more points in the MGS. They were considered as improved if the reduction in MGS was by 2 or 3 points but not 4. The patients who showed a reduction of less than 2 points were considered to be not improved.
Results
Baseline Demographics
Group A (n = 24) Group B (n = 26)
Age (mean + SD) 32.88 + 6.9 30.42 + 6.7
Male (N) 11 13
Female (N) 13 13
Mean Grading Score (MGS)
Comparison of Mean Grading Score at Baseline and End of Study (EOS) (N = 46)
Group A (n = 22) Group B (n = 24) P Value
Baseline 6.7 ± 1.2 6.4 ± 0.8 0.39
EOS 3.9 ± 1.5 3.8 1.4 0.72
P Value <0.0001 < 0.0001 <0.0001
The study included 26 females divided equally in group A (13 patients) and group B (13 patients) respectively. 24 males were part of the study. The total number of dropouts was 4 patients.
Graph 1: MGS at Baseline vs at EOS
The MGS for Group A was 6.7 (±1.2) compared 6.4 (±0.8) at the baseline. At end of study (after 3 months), the mean value of MGS in group A was 3.9 (± 1.5) (P < 0.0001). In Group B, the mean value of MGs was 3.8 (± 1.4) (p<0.0001).
Percentage of cases Improved vs Not Improved vs Recovered in both groups
Medicine A (n = 22) Medicine B (n = 24)
Not Improved 27 21
Improved 41 58
Recovered 32 21
In Group A, 32% of patients were found to be recovered (4 or more than 4 point reduction in MGS at EOS).41 % of the patients showed improvement(2 to 3 point reduction in MGS at EOS) whereas, 27% of patients didn’t show any improvement at all.
In Group B, 21% of patients were found to be recovered compared to baseline. 58% of patients were improved whereas 21 % of patients did not show any improvement at all.
Graph 2: Percentage of cases Improved vs Not Improved vs Recovered in both groups
Discussion
Clinical symptom with change in the baseline score of ringworm values for pre- and post-treatment analysis was used as an assessment tool to evaluate whether the primary aim was achieved or not and observed results were corroborated by applying required statistical test viz. standard deviation, standard error of the mean, calculation of the mean, Paired t test. Significant symptomatic relief has been observed in patients with tinea corporis with both the medicines at the end of study. However, the efficacy of two medicine was comparable and there was no difference in two groups.
Conclusion
From the present study, it can be concluded that in the patients of tinea corporis, Nyctanthes Arbortristis 30C (either prepared from leaves or prepared from seeds of plant) is effective in giving symptomatic relief in terms of improvement in lesion score which was assessed using parameters like itching, erythema, vesicles, scaling and discoloration. However, there was no difference in efficacy when the two products, i.e. Nyctanthes Arbortristis 30C prepared from the leaves and Nyctanthes Arbortristis 30C prepared from the seeds, were compared against each other.
Future multicentric studies with larger sample size and longer duration would be needed to substantiate the results of present study. Studies in different environmental condition i.e. tropical, temperate etc. as well as in different climatic seasons would help to understand the optimum benefits of Nyctanthes Arbortristis 30C in the management of tinea corporis.
Acknowledgement: The study was executed under Dr Dinesh Kumar Goyal (Supervisor).
Author:
Dr Chauhan Sudhir Shyamvachan
Reader, Department Of Homoeopathic Pharmacy
B.A. Dangar Homoeopathic Medical College and Hospital, Rajkot, Gujrat.
Ph.D. Scholar ( Homoeopathic Pharmacy)
Homoeopathy University, Jaipur, Rajasthan

Chauhan Sudhir Shyamvachan
Posted By: Chauhan Sudhir Shyamvachan

Reader, Department of Homoeopathic pharmacy Shri B A Dangar Homoeopathic medical college, Rajkot, Gujrat PH. D scholar, Homoeopathy University, Jaipur, Rajasthan