| CTRI Number |
CTRI/2025/07/090588 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Haritaki Lepa And Manjistha Lepa In Savarnikarana Of Rudha Vrana (Healed Wound) With Special Reference To Scar |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Manjistha Lepa And Haritaki Lepa In Savarnikarana Of Rudha Vrana With Special Reference To Scar |
| 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 Priyanka Anand Hasbe |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduation And Research Center Ashta |
| Address |
opd no 14 ground floor Shalyatantra department Dhanwantri hospital -Hon Shri Annasaheb ayurvedic Medical college and post graduate and research centre ashta sangli
416301
Maharashtra
Sangli
MAHARASHTRA
411015
India |
| Phone |
7522967742 |
| Fax |
|
| Email |
priyahasbe928@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center ashta |
| Address |
opd no 14 ground floor Shalyatantra department Dhanwantri hospital -Hon Shri Annasaheb ayurvedic Medical college and post graduate and research centre ashta sangli
416301
Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akbar Walandkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center ashta |
| Address |
opd no 14 ground floor Shalyatantra department Dhanwantri hospital -Hon Shri Annasaheb ayurvedic Medical college and post graduate and research centre ashta sangli
416301
Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal-Walwa Dist- Sangli Pincode 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Anand Hasbe |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal-Walwa Dist- Sangli Pincode 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 Priyanka Anand Hasbe |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanwantri hospital ashta |
OPD NO 13 Shalyatantra opd Ground Floor Dhanwantri Ayurvedic Hospital Ashta Taluka Walwa District Sangli Sangli
Maharashtra
Pune
MAHARASHTRA |
7522967742
priyahasbe928@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 And Post Graduate And Research Center Ashta Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: RUHYAMANAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: haritaki, Reference: sushrut samhita chikitsa sthan verse 1/95, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: manjistha, Reference: charak samhita sutra sthan verse 4/8, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 18to50 years
Patients with scar or pigmentation of skin after wound healing
Post operative scar
Size of the scar measuring upto 5cm length 5cm breadth |
|
| ExclusionCriteria |
| Details |
Patient having malignancy
Patiens suffering from skin disease like leucoderma leprosy was excluded
Patient having keloid
Hypertrophic scar
Patient suffering from hiv and hbsag |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of manjishtha lepa and haritaki lepa in savarnikarana of rudhavrana. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review the literature of rudhavrana and scar in Ayurveda and modern science
To observe the adverse drug reaction of manjisthalepa and Haritaki lepa in savarnikarana of rudhavrana
To compare the efficacy of manjishtha lepa and haritaki lepa in savarnikarana of rudha vrana |
4 weeks |
|
|
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)
|
15/08/2025 |
| 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
|
As we know the cosmetic procedures in the present era are mostly invasive costlier with considerable side effect and are not so feasible to common man. So there is need of ayurvedic remedies in cosmetology which will be easily available with good outcomes and deviod of side effects. My aim for this study is reduce the discloloration and pigmentation of rudha vrana and to comapre haritaki lepa and manjistha lepa in savarnikarana of rudha vrana my trial drug for this study is haritaki and cotrol drug is manjistha . Procedure is for 7days and follow up is for 7 14 and 28 days 34 Patients in each group will be studied.Study will be conducted in india Outcome of study will be assessed on reduction of sign and symptoms of rudha vrana . |