| CTRI Number |
CTRI/2023/05/052839 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
17/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study of Shigru (Moringa oleifera) stem bark and root bark lepa on dadru kushtha (dermatophytosis/ringworm) |
|
Scientific Title of Study
|
Assessment of comparative efficacy of Shigru (Moringa oleifera LAM.) stem bark and root bark lepa on dadru kushtha- A randomized comparative clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Kumari |
| Designation |
PG scholar |
| Affiliation |
All india institute of ayurveda |
| Address |
Dravyaguna vigyana department, academic block, room number- 219, second floor, All india institute of ayurveda, gautampuri awas, sarita vihar, mathura road, south delhi- 110076
South
DELHI
110076
India |
| Phone |
8700479820 |
| Fax |
|
| Email |
archana.kumari.ak85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhargav Vijay Bhide |
| Designation |
Assistant professor, Department of dravyaguna vigyana |
| Affiliation |
All india institute of ayurveda |
| Address |
Academic block, room number- 202, second floor, All india institute of ayurveda, gautampuri awas, sarita vihar, mathura road, south delhi - 110076
South
DELHI
110076
India |
| Phone |
9372308023 |
| Fax |
|
| Email |
bhargava.183@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Vijay Bhide |
| Designation |
Assistant professor, Department of dravyaguna vigyana |
| Affiliation |
All india institute of ayurveda |
| Address |
Academic block, room number- 202, second floor, All india institute of ayurveda, gautampuri awas, sarita vihar, mathura road, south delhi - 110076
South
DELHI
110076
India |
| Phone |
9372308023 |
| Fax |
|
| Email |
bhargava.183@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of ayurveda, gautampuri awas, sarita vihar, mathura road, south delhi - 110076 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI - 10076 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARCHANA KUMARI |
All india institute of ayurveda |
OPD number-8, Hospital block, All india institute of ayurveda, gautampuri awas, sarita vihar, delhi-110076
South
DELHI |
08700479820
archana.kumari.ak85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shigru stem bark, Reference: sharandhar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chakramarda beeja, Reference: Bhavprakash nighantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: Yes, Route: water, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shigru root bark, Reference: vangsena samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A. Patient with 21 to 60 years of age(in completed years) willing to participate in the study.
B. Patient with classical sign and symptoms of Dadru kushtha with positive KOH mount test of skin sample.
C. Patient belonging to either gender will be included in the study. |
|
| ExclusionCriteria |
| Details |
A. Patient with known case of skin cancer, skin tuberculosis, scabies, psoriasis, contact dermatitis, candidiasis, malignant infection, secondary infections.
B. Dadru kushtha chronicity more than 3 years
C. Patient suffering from systemic illness under medications that could affect the study results.
D. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
More than 40 % improvement in clinical sign and symptoms i.e. kandu(itching), Raga(skin colour), Pidika(number of papules per mandala), Utsanna mandala(number of elevated circular patch, Utsanna mandala(size of elevated circular patch in cm) of Dadru kushtha at 7 days interval of 21 days of study.
|
assessment will be done at day 0,7,14,21 and follow up at day 31 and day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of patients assessed using DLQI at 7 days interval of 21 days of study. |
Assessment will be done at day 0,7,14,21 and follow up at day 31 and day 42 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO PUBLICATION DONE TILL DATE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [archana.kumari.ak85@gmail.com].
- For how long will this data be available start date provided 06-10-2024 and end date provided 06-10-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Shigru (Moringa olifera Lam.) is a plant having multitude of uses be it therapeutic or nutraceuticals. The existing treatment protocol for Dadru kushtha (dermatophytosis) consists of various topical and oral steroids, antifungal creams and medication that gives temporary relief which on prolonged consumption causes hepatotoxicity and hormone related effects. Therefore in a recurrent condition like Dadru there is need for safe, efficacious, cost effective management thus a study on shigru is taken. Acharaya Vangasena depicted in kushtha chikitsa to use Shigru root bark lepa as an effective remedy in Dadru kushtha. As the use of root bark may lead to the destruction of plant, it needs to be replaced by another part if possible. Hence considering similar activity in stem bark, this study emphasizes on the comparative analysis and clinical efficacy of stem bark lepa with that of root bark lepa. |