| CTRI Number |
CTRI/2026/02/103469 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized trial to evaluate effect of Varun Patra Churna with Shatdhaut ghrita in management of stretch marks during pregnancy |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect of Varun Patra Churna with Shatdhaut Ghrita in the management of Garbhini Kikkisa with special reference to Striae Gravidarum |
| 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 Jaya Shivaji More |
| Designation |
PG Scholar |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Chhatrapati Sambhajinagar |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Stree roga evum Prasuti Tantra Department, Hospital Building 4th Floor, Nipani Bhalgaon, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7378581492 |
| Fax |
|
| Email |
jayamore1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Desai |
| Designation |
PROFESSOR |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital,Chhatrapati Sambhajinagar |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Stree roga evum Prasuti Tantra Department, Hospital Building 4th Floor, Nipani Bhalgaon, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9511716046 |
| Fax |
|
| Email |
drshilpadesai81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Desai |
| Designation |
PROFESSOR |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital,Chhatrapati Sambhajinagar |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Stree roga evum Prasuti Tantra Department, Hospital Building 4th Floor, Nipani Bhalgaon, Chhatrapati Sambhajinagar
MAHARASHTRA
431005
India |
| Phone |
9511716046 |
| Fax |
|
| Email |
drshilpadesai81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Stree roga evum Prasuti Tantra Department, Nipani Bhalgaon, Chhatrapati Sambhajinagar 431005 |
|
|
Primary Sponsor
|
| Name |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital |
| Address |
Nipani Bhalgaon, Near Videocon company Ltd, Beed Highway, Chhatrapati Sambhajinagar,Maharashtra,
India 431007 |
| 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 Jaya Shivaji More |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital, Stree roga evum Prasuti Tantra Department, Hospital Building 4th Floor, Nipani Bhalgaon, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA |
07378581492
jayamore1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varun Patra Churna, Reference: Chakradatta Striroga Chikitsa 63/32, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Shatdhaut Ghrita), Additional Information: Apply lep of Varun Patra churna with Shatdhaut ghrita all over the abdomen and thigh region as much needed, daily at night before sleep and leave it overnight | | 2 | Comparator Arm (Non Ayurveda) | | - | StrechNil cream | Apply all over the abdomen and thigh region as much needed, daily at night before sleep and leave it overnight |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with gestational age 5 months onward upto delivery
Patients having classical sign and symptoms of Kikkis as per prepared performa
primi gravida patient will be selected |
|
| ExclusionCriteria |
| Details |
Multi gravida
Patient having skin disease
High risk gravida
Known case of any pathology which can affect the result of the trial example liver disease |
|
|
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 compare the efficacy of Varun Patra Churn wuth Shatdhaut ghrita and Strech nil cream in the management of Garbhini kikkisa with special reference to Striae gravidarum |
At 4th week and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To carry out a comprehensive literary study of Gharbghini kikkis and Striae Gravidarum from modern science |
To carry out a comprehensive literary study of Gharbghini kikkis and Striae Gravidarum from modern science |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/02/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Striae gravidarum are the slightly depressed linear marks with varying length and breadth found in pregnancy.They are predominantly found in the abdominal wall below the umbilicus.These strech marks represent the scar tissues in the deeper layer of the cutis.Initially these are pinkish but after the delivery the scar tissues contract and obliterate the capillaries and they become glistening white in appearance and are called striae albicans.Apart from the mechanical stretchning of the skin, increase in the aldosterone prodution during pregnancy are the responsible factors.Kikkisa is seen in 67% of all the pregnant women.It is the major problem of modern cosmetic era and hence it requires proper medical treatment which is cost effective and less side effect. Varun patra churna with Shatdhaut ghrita are mentioned in Chakrapani Samhita for the management of garbhini kikkisa. By taking these drug in consideration,I am going to prepare Churna which is easy to apply and it is cost effective. so, present study is to evaluate the efficacy of Varun Patra churna with Shatdhaut ghrita in the management of Garbhini Kikkisa is being proposed. |