| CTRI Number |
CTRI/2025/04/084041 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study The Effect Of Ashwagandhadi Lepa In The Management Of Shuddha vrana |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL TRIAL TO STUDY THE EFFICACY OF
ASHWAGANDHADI LEPA IN THE MANAGEMENT OF SHUDDHA VRANA
W.S.R. TO NON INFECTIVE WOUND |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Yadavrao Wanje |
| Designation |
MS Scholar Shalyatantra Samanya |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved
Mahavidyalaya And Hospital ,Kamal nagar Hiravadi, Panchavati,
Nashik
MAHARASHTRA
422003
India |
| Phone |
9527251129 |
| Fax |
|
| Email |
shraddhawanje2808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved
Mahavidyalaya And Hospital ,Kamal nagar Hiravadi, Panchavati
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved
Mahavidyalaya And Hospital ,Kamal nagar Hiravadi, Panchavati
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Medical College And Hospital , KamalNagar , Hirawadi ,
Panchvati,Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 |
| Type of Sponsor |
Private medical college |
|
|
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 Shraddha Yadavrao Wanje |
Shree Saptashrungi Ayurveda mahavidyalaya and hospital |
Shree saptashrungi Ayurveda mahavidyalaya, hirawadi, panchavati, nashik, 422003
Nashik
MAHARASHTRA |
9527251129
shraddhawanje2808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T148||Other injury of unspecified body region. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Hydrogel | AMORPHOUS HYDROGEL(CONTROL GROUP)
â–ª Hydrogel is a water-swollen, and cross-linked polymeric network produced
by the simple reaction of one or more monomers.
â–ª Chemical composition: Hydrogels may be based on natural polymers,including
macromolecules extracted from animal collagen, plants, and seaweed. These natural
macromolecules are typically polysaccharides and proteins comprised of glycosidic
and amino acid repeating units, respectively.
â–ª Action of drug: It promotes healing by enhancing automatic debridement and
moisturising the wound bed which promotes granulation and re-epithelization.
â–ª Unlike other topical drugs it is easy to remove without damaging newly
differentiated keratinocytes or may not be necessary to remove due to
biodegradability.
â–ª Properties can be added without any adverse effects.
â–ª Available in sheet, amorphous, impregnated or spray able forms. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi lepa, Reference: Bhavaprakash nighantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: .. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having vrana in Shuddha awastha. 2) Patients irrespective of sex, religion, occupation etc. 3) Dimension of wound upto 32sq.cm. 4) Wounds which are present to extremities only. 5) Patients either Age between 15 to 60 year |
|
| ExclusionCriteria |
| Details |
) Wounds not having signs-symptoms of Shuddha vran or are Dushta. 2) Patients having bleeding disorder. 3) Wounds of size more than 32sq.cm. 4) Diagnosed patients of AIDS, Diabeties mallitus, Hepatitis B., Tuberculosis and
immune-compromised. 5) Patients with anemia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce sign and symptoms and enhance healing of shuddha vrana |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shuddha vrana is completely treated |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2025 |
| Date of Study Completion (India) |
18/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
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)
|
Primary objective : To study the efficacy of Ashwagandhadi lepa in the management of Shuddha vrana . Secondary objective: 1) To Study Shuddha vrana in detail as per Ayurvedic and modern aspect. 2) To study the ropan effect of trial drug i.e Ashwagandhadi lepa and Hydrogel.
Study population: It will be selected from patients attending OPD and IPD Duration of study - 18 months Duration of treatment -7 days (Further Follow up on 14th and 21st day)
30 patients will be taken in each group
Sampling technique: Simple Randomized sampling will be done for 60 patients of age group 15 to 60 years.
Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents. |