| CTRI Number |
CTRI/2026/02/103632 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [LEPA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Two Ayurvedic Herbal Applications on Improving Scar Color A Clinical Comparison |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AJADUGDHA BHAVITA KATUTUMBIPHALA LEPA AND AJADUGDHA BHAVITAROHINIPHALA LEPA ON SAVARNIKARANA OF VRANA VASTU W.S.R. 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 |
DrKrupa S Vyas |
| Designation |
PG SCHOLAR |
| Affiliation |
shree swaminarayan ayurvedic college kalol |
| Address |
Department of Shalyatantra Shree Swaminarayan Ayurvedic
College Ahmedabad-Mehsana Highway AT and PO Saij Ta Kalol
Dist Gandhinagar 382725
Gandhinagar
GUJARAT
382725
India
Gandhinagar
GUJARAT
382725
India |
| Phone |
8849871254 |
| Fax |
|
| Email |
kv6231583@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DARSHANA RAMOLE |
| Designation |
B.A.M.S MS (AYU.)HEAD OF DEPARTMENT (SHALYA TANTRA) |
| Affiliation |
shree swaminarayan ayurvedic college kalol |
| Address |
Department of shalyatantra Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar
382725 GUJARAT India
Gandhinagar
GUJARAT
382725 India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR DARSHANA RAMOLE |
| Designation |
B.A.M.S MS (AYU.)HEAD OF DEPARTMENT (SHALYA TANTRA) |
| Affiliation |
shree swaminarayan ayurvedic college kalol |
| Address |
Department of shalyatantra Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar
382725 GUJARAT India
Gandhinagar
GUJARAT
382725 India
GUJARAT
382725
India |
| Phone |
9970728218 |
| Fax |
|
| Email |
drdarshna@swaminarayanuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic College |
| Address |
Faculty of Ayurved Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar
382725 GUJARAT India |
| 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 Krupa S Vyas |
Premswarup Swami Ayurvedic Multispecialty Hospital |
OPD 006 Department of shalya tantra Premswarup Swami Ayurvedic
Multispeciality Hospital Ahmedabad-Mehsana Highway At Po Saij Ta Kalol Dist
Gandhinagar 382725 GUJARAT Gandhinagar GUJARAT
Gandhinagar
GUJARAT |
8849871254
kv6231583@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| swaminarayan university institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L905||Scar conditions and fibrosis of skin. Ayurveda Condition: VRANA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta Samhita, Chikitsa Sthana, Chapter 1, Shlokas 14–15, Procedure details: Clean the affected area with Saline water
Applied once daily a thin layer of Ajadugdha Bhavita katutumbiphala lepa mixed with goghrita over the scar hyperpigmented area
Left for 30 minutes then washed gently with lukewarm water
Duration Total duration 6 weeks)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta Samhita, Chikitsa Sthana, Chapter 1, Shlokas 14–15, Procedure details: Clean the affected area with Saline water
Applied once daily a thin layer of Ajadugdha Bhavita Rohiniphala lepa mixed with go goghrita over the scar hyperpigmented area
Left for 30 minutes then washed gently with lukewarm water
Duration Total duration 6 weeks)
|
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 8 60 years
Presence of post healed completely epithelialized Vrana scar with persistent abnormal pigmentation or visible scar remodelling 1 month to 12 months after wound epithelialization
Scar area less than or equal 10 cm² and depth limited to superficial or dermal scars excluding full thickness grafted areas or deep contractures
Scar types post surgical post traumatic or post inflammatory scars non infective
Scar stable for greater than or equal 2 weeks with no active infection or recent expansion.
Willing to avoid other topical systemic scar treatments during the study and attend follow up visits
Able to give informed consent and comply with study procedures
|
|
| ExclusionCriteria |
| Details |
Malignancy
Keloid or severe hypertrophic scar
Patients suffering from skin diseases like leucoderma leprosy eczema or psoriasis
Active local infection at scar site
Scars resulting from major burns or grafted areas
Recent use of topical systemic corticosteroids, retinoids chemical peels lasers or dermabrasion within 3 months
Known allergy or hypersensitivity to any component of the trial medications
Uncontrolled systemic diseases affecting wound healing diabetes greter than250mg per dl vascular disease severe hepaticrenal impairment
Pregnant or lactating women
Bleeding disorders or on anticoagulant therapy
Psychiatric or cognitive conditions impairing consent or compliance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim of this study is to evaluate the effecacy of Ajadugdhabhavita katutumbiphala lepa and Ajadugdhabhavita Rohiniphala lepa in the management of savarnikarana of varana vastu |
Base line and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the Itching Pigmentation improve in skin texre and complextion |
Base line and 4th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/02/2026 |
| 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="0"
Months="11"
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
|
Scars and dark marks left on the skin after injuries or surgery are very common Even when a wound heals completely the skin often becomes darker uneven or thickened which affects appearance and confidence Modern treatments like laser therapy chemical peels and steroid creams are available but they are costly may cause side effects and are not always suitable for everyone Ayurveda offers natural options that may help in reducing scar marks and improving skin tone This study aims to compare the effect of two Ayurvedic ointments AjadugdhabhavitaKatutumbi Phala Lepa and AjadugdhabhavitaRohiniphala Lepa in lightening scars and restoring normal skin colour Both these herbal medicines are described in classical Ayurvedic texts for improving wound healing and reducing dark pigmentation Rohini is known for enhancing complexion healing tissues and reducing inflammation Katutumbi bottle gourd fruit is traditionally used to purify blood decrease pigmentation and support healthy skin renewal A total of 40 patients with post healed scars will be selected and divided into two groups One group will use Katutumbi lepa while the other group will apply Rohiniphala lepa Both will be used daily for four weeks followed by two weeks of observation The improvement in scar colour texture itching and appearance will be measured with clinical scales and patient feedback The goal of this research is to find out which ointment works better for reducing pigmentation and improving the look of healed scars If effective these herbal ointments could become a safe affordable and easily accessible treatment option for people dealing with dark scars helping them regain skin uniformity and confidence naturally |