| CTRI Number |
CTRI/2026/03/106227 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An clinical trial of Haridra lepa for 7 days in the management of post operative wound as antiseptic |
|
Scientific Title of Study
|
An open randamized contol clinical trial Of Haridra lepa in the management of post operative wound as antiseptic |
| 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 Kartiki Devram Mane |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved
Medical College Post Graduate and Research Centre Ashta Tal
Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9766589791 |
| Fax |
|
| Email |
manedkartiki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushant Rajaram Jagdale |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9561731366 |
| Fax |
|
| Email |
sushant.jagdale27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushant Rajaram Jagdale |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post
Graduate and Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9561731366 |
| Fax |
|
| Email |
sushant.jagdale27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tal Walwa Dist Sangli Maharashtra 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Kartiki Devram Mane |
| Address |
Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta
Tal Walwa Dist Sangli Maharashtra 416301 |
| 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 Kartiki Devram Mane |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Sangli |
Department of Shalya Tantra OPD No 13 Dhanwantri Hospital Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre A/P Ashta Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA |
9766589791
manedkartiki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Sangli |
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: SASTRAKARMA-APACARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Dravyaguna vigyan Uttaradha yadavji, Procedure details: Purvakarma
Patient will be explained about the procedure and informed consent will be obtained.
Post operative wound will be assessed based on subjective and objective parameter.
Pradhankarma
Post operative wound will be cleaned by normal saline.
The paste of prepared Haridra lepa will be applied in pratiloma direction on post operative wound.
Paschatkarma
Wipe out Haridra lepa with normal saline once its been dired. Sterile gauze will be placed over the wound and bandaging will be done.
Patient will be observed daily for 7 days.)
(1) Medicine Name: Haridra Churna, Reference: Bhavaprakash Nighantu Haritakyadi Varga, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine Ointment | Povidone-iodine is a PVP–iodine complex containing 9–12% available iodine. It is a widely used antiseptic that kills bacteria, fungi, viruses, and protozoa by slowly releasing iodine, which helps reduce toxicity to human cells. It is used as an antiseptic for post-operative wounds and will be applied once daily (OD) for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Post operative patients of minor surgeries like corn excision, lipoma
excision, fibro adenoma, incision and drainage, nail excision.
2 Subject with Lakshanas of Sadyovrana .
3. Wound size up to 5 centimetres
4. All linear wounds (Limbs) like CLW. |
|
| ExclusionCriteria |
| Details |
1.Patient Suffering from dustavrana (Non healing wounds)
2. Patient with known history of DM, HIV, HBsAG, Tuberculosis or
any other systemic.
3. Malignant ulcer.
4. Anorectal diseases.
5. Ulcer due to radiation therapy.
6. Features showing gangrene.
Any complication will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haridra lepa 1g for 7 days is effective in
post operative wound management |
1 to 7 post operative days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
01/04/2026 |
| 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
|
In modern medical science a wound is defined as a disruption
or break in the continuity of the skin or surface epithelium. Acharya Sushruta
Honor as the father of surgery begins the Chikitsa Sthana section of the
Sushruta Samhita with a comprehensive discussion on Vrana highlighting the
importance and detailed understanding of wound care in ancient Indian medical
science.For effective management of such conditions Acharya Sushruta in
Chikitsa Sthana has elaborated the Shashti Upakrama. Among the many procedures
recommended by Sushruta, lepa holds a significant role in vrana management. According to Yadavji Trikamji wet medicinal drugs are made
in paste form or the drugs in dry form they are convert into the paste form
with help of prescribed liquid media or water and grind it. This prepared Lepa
is use external application called as Lepa Kalpana.
Bhavaprakasha has praised Haridra for its vranaropana
qualities which is useful in wound healing as antiseptic nature. The current
research explores the role of such Ayurvedic interventions particularly Haridra
in the efficient management and healing of wounds. |