| CTRI Number |
CTRI/2024/11/077346 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the Effect of Shigrumoolatwak lepa in the treatment of Dadru |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Shigrumoolatwak lepa (Moringa oleifera) in the management of Dadru(Tinea) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Bhausaheb Ahire |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research centre, Pimpri, Pune |
| Address |
OPD no 5 and IPD of Kayachikitsa department, Dr. D. Y. Patil College of Ayurved and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8805995944 |
| Fax |
|
| Email |
rutujaahire1415@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunvant Yeola |
| Designation |
M.D. Ph.D. Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research centre, Pimpri, Pune |
| Address |
OPD no 5 and IPD of Kayachikitsa department, Dr. D. Y. Patil College of Ayurved and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Bhausaheb Ahire |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research centre, Pimpri, Pune |
| Address |
OPD no 5 and IPD of Kayachikitsa department, Dr. D. Y. Patil College of Ayurved and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8805995944 |
| Fax |
|
| Email |
rutujaahire1415@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y. Patil College of Ayurveda and Research Centre,Sant Tukaram Nagar,Pimpri, Pune, Maharashtra, India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Rutuja Bhaussaheb Ahire |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rutuja Bhausaheb Ahire |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
OPD no 5 and IPD of Kayachikitsa department, Dr.D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
8805995944
rutujaahire1415@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, 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: shigrumoolatwak lepa, Reference: vangsen samhita, kushtarogadhikar,slok no 66 , page no 623, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -churna of shigrumoolatwak mixed with quantity sufficient water to make paste form |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Dadru i.g. Kandu(Itching), Daha(burning sensation), Raga(erythema), Pidaka(eruption) and Utsanna mandala(elevated circular lesions) irrespective of chronicity. |
|
| ExclusionCriteria |
| Details |
Patient suffering from chronic illness and infection like Psoriasis, Hansens disease, Generalized eczema and Malignant conditions.
Lesions with secondary infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kandu(Itching), Daha(burning sensation), Raga(erythema), Pidaka(eruption) and Utsanna mandala(elevated circular lesions) |
14 days with follow ups on 7th and 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find any new etiological factors of Dadru based on present day lifestyle and other factors. |
14 days with follow ups on 7th and 14th day. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TO STUDY THE EFFICACY OF SHIGRUMOOLA TWAK LEPA ON 45 PATIENTS SUFFERING FROM DADRU 3gm to 10gm of Shigrumoolatwak lepa will mix with quantity sufficient water to make paste form and apply externally over the affected area for the duration of 14 days. Follow up will on 7th and 14th day. Final conclusion will be drawn on the basis of statistical methods. |