| CTRI Number |
CTRI/2025/05/086613 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of local application of Kutajadi Cream and Karveer Patra Cream on Pregnancy Stretch Marks |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study of Local Application of Kutajadi Cream and Karveer Patra Cream in the Management of Garbhini Kikkis 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 |
Mahesh Gopal Pawane |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of Prasuti Tantra and Stri Roga Third floor APMs Ayurved Mahavidyalaya Near Sion Railway Station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7219123727 |
| Fax |
|
| Email |
drmaheshgpawane2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahesh Gopal Pawane |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of Prasuti Tantra and Stri Roga Third Floor APMs Ayurved Mahavidyalaya Near Sion Railway Station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7219123727 |
| Fax |
|
| Email |
drmaheshgpawane2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Gopal Lamture |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of Prasuti Tantra and Stri Roga Third Floor APMs Ayurved Mahavidyalaya Near Sion Railway Station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9819865834 |
| Fax |
|
| Email |
drplamture@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth R. V. Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurved Hospital |
| Address |
Near Sion Railway Station, Sion East, Mumbai 400022 |
| Type of Sponsor |
Other [Charitable Ayurvedic Hospital ] |
|
|
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 Mahesh Gopal Pawane |
Seth R. V. Ayurved Hospital |
OPD no 8 Department of Prasuti Tantra and Stri Roga Seth R V Ayurved Hospital Near Sion Railway Station Sion East Mumbai 400022
Mumbai
MAHARASHTRA |
7219123727
drmaheshgpawane2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O94-O9A||Other obstetric conditions, not elsewhere classified. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutajadi Cream, Reference: Charak Samhita Sharirsthan Adhyay 8 Jatisutriya Adhyay Shlok no 32, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karveer Patra Cream , Reference: Charak Samhita Sharirsthan Adhyay 8 Jatisutriya Adhyay Shlok no 32, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida Patients
Patients having symptoms of Kikkis in 2nd and 3rd trimester
Pregnant Patients of age group 20-40years
Voluntary Willing Patients
Patients from all Socio-ecnomical class |
|
| ExclusionCriteria |
| Details |
Multipara Patients
Multiple Pregnancy e.g. Twin pregnancy
Pregnant Patients with other Skin Disesase or Skin Allergy Over Abdomen
Patients having complications of pregnancy e.g. Polyhydromnios, PIH, Gestational Diabetes
Patient having HIV, HbsAg, HCV, VDRL Positive |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Daha- Burning sensation
Kandu- Itching
Vaivarnya- Discolouration
Size and Number of Striae lesion |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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 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
|
Kikkis, also known as Striae Gravidarum, is the most common disorder that causes stretch marks to appear predominantly on the abdomen and thigh regions of pregnant women. In India, the prevalence rate of Striae Gravidarum is 80.78%, indicating poor skin elasticity among women. Symptoms of Kikkis include severe Daha, Kandu, and Vaivarnya, which significantly affect the daily lives of women during pregnancy. Ancient texts by Acharya Charaka and Vagbhata explain the pathophysiology of Kikkis, stating that the growing fetus displaces all doshas in an upward direction, leading to the vitiation of these doshas. Vitiated vata dosha result in Twak Vaivarnya (Skin Discolouration), due to Pitta dosha Daha (burning sensations) and Kandu (itching) due to Kapha dosha. Ayurvedic treatments have been found to have minimal adverse effects, are cost-effective, and have been proven effective in treating dermatological disorders. The Kutajadi cream contains the ingredients Kutaja, Arjaka beeja, Haridra, and Musta. Kuataja having Kandughna,Vranaropak,Raktashodhan,Raktastambhak properties &having strong Astringent,Antiinflammetory action. Arjaka beeja having Snehan,Dahaprashaman,Vranaropak,krimighna,Shothahar properties and shows Antioxident,Antiinflammatory,Antihistaminic action. Musta is kandughna,Shothahar,Raktaprasadak & oils have analgesic and antiinflammetory action. Haridra is Varnya, Kandughna, Kushthaghna, Vednasthapaka, Vranropak,Vranshodhaka,Raktawardhan properties & Analgesic,Antibacterial,antihistaminic,Anticeptic,Antioxident action. Overall, Kutajadi cream combines properties that address itching (Kandughna), improve skin quality (Varnya), alleviate burning (Dahaprashamaka), relieve pain (Vedanashamak), and possess antihistaminic and anti-inflammatory effects, making it effective in reducing the symptoms of Kikkis. |