| CTRI Number |
CTRI/2025/07/089920 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The management of ringworm (Dadru/Tinea infection)with Siravedh(Ayurvedic Blood letting) followed by a herbal paste (Dadrukushtahar lepa) helps better in treatment. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to assess the add on effect of Siravedh followed by Dadrukushtahar lepa in Dadru w.s.r Tinea infection. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrutika Jalandar Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre,panchkarma department OPD Kodoli,Tal.Panhala, Dist. Kolhapur,State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329823529 |
| Fax |
|
| Email |
patilshrutika4599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikumar Bhagwan Patil |
| Designation |
MD PhD Panchkarma Professor and HOD of Panchkarma Department |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, panchkarma department OPD Kodoli, Tal.Panhala, Dist. Kolhapur,State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822010316 |
| Fax |
|
| Email |
vaidyaravipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrutika Jalandar Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre,panchkarma department OPD Kodoli,Tal.Panhala, Dist. Kolhapur,State Maharashtra, 416114,India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329823529 |
| Fax |
|
| Email |
patilshrutika4599@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr. Shrutika Jalandar Patil |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept Yashwant Ayurvedic
College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist
Kolhapur 416114 |
| 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 Shrutika Jalandar Patil |
Yashwant Dharmartha Rugnalay |
Yashwant Ayurvedic College
Post GraduateTraining and
Research Centre, Kodoli
Panchkarma OPD Ground floor
and IPD Second floor, Room No.
4 Panchakarma department.
Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8329823529
patilshrutika4599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: siravedh with dadrukushtahar lepa, Reference: Sushrut Samhita of Maharshi Sushruta with Sushrutavimarsini Hindi commentary by Dr. Anant Ram Sharma forwarded by Acharya Priya Vat Sharma, Chaukhambha Surbharati Publication, Varanasi 2022, Sharirsthana Chapter 8 Siravyadhvidhi Adhyay, Shloka No.23 and 26, Page No-115-116. Rasendra Mangal Of Nagarjuna, Part 1 by Kaviraj H.S.Sharma forwarded by Acharya P,V. Sharma, Choukhamba Orientalia, Varanasi, Chapter 3, Shloka No. 137, Page No. 90, Route: Topical, Dosage Form: Lepa Churna, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -1 sittings of Siravedha Karma(about 60ml)weekly once.
Lepa(width 0.5cm) twice a day for(100 matra) Approximately 1min / 15 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: dadrukushtahar lepa, Reference: Rasendra Mangal Of Nagarjuna, Part 1 by Kaviraj H.S.Sharma forwarded by Acharya P,V. Sharma, Choukhamba Orientalia, Varanasi, Chapter 3, Shloka No. 137, Page No. 90, Route: Topical, Dosage Form: Lepa Churna, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Lepa(width 0.5cm) twice a day for(100 matra) Approximately 1min / 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having signs and symptoms Kandu, Mandal, Daha, Pidika of Dadru Kushtha will be selected irrespective of gender.
2)Age between 18-60 years
3)Patient fit for Siravedh. |
|
| ExclusionCriteria |
| Details |
1)Patient on medication of anticoagulant.
2)Patients with hemophilic disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the add on effect of Siravedha with Dadrukushthar Lepa in the management of dadru kushtha w.s.r to tinea infection. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To reduce sign and symptoms of dadru kushta.
2. To assess the improvement by sign and symptoms and gradation of assessment criteria.
3. To study the etiopathogenesis and clinical features of dadru according to Ayurveda.
4. To improve quality of life and reduce discomfort of patients. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomized open controlled clinical study to assess the add on effect of Siravedh followed by Dadrukushtahar lepa in dadru w.s.r tinea infecton. The assesment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 15 days. |