| CTRI Number |
CTRI/2025/06/089331 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Use of Ayurvedic Manjishtadi Lotion to Prevent and Treat Striae Gravidarum (stretch marks of pregnancy) |
|
Scientific Title of Study
|
An Open Labelled Clinical Trial on Preventive and Curative Effect of Manjishtadi Lotion on Kikkisa w.s.r. 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 Pranali Laxman Gawade |
| Designation |
Post Graduate Resident in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 |
| Address |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 Taluk Chikkodi Dist Belgaum Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
9518959948 |
| Fax |
|
| Email |
plgawade97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sayali Vijaykumar Pashte |
| Designation |
Associate Professor |
| Affiliation |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 |
| Address |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 Taluk Chikkodi, Dist Belgaum, Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
8779186547 |
| Fax |
|
| Email |
sayali90p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sayali Vijaykumar Pashte |
| Designation |
Associate Professor |
| Affiliation |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 |
| Address |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213 Taluk Chikkodi, Dist Belgaum, Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
8779186547 |
| Fax |
|
| Email |
sayali90p@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213 |
|
|
Primary Sponsor
|
| Name |
Dr Pranali Laxman Gawade |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213 |
| 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 Pranali Laxman Gawade |
OPD and IPD, Department of Prasuti Tantra Evum Stree Roga |
Dr N A Magadum Ayurvedic Medical college hospital and research center Ankali 591213
Belgaum
KARNATAKA |
09518959948
plgawade97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. NAMAMC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primi-gravida |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi Lotion , Reference: Charak Samhita Sutrasthana, Dravyaguna vidnyana Acharya Priyavat Sharma , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Manjishtadi Lotion is an Anubhuta Yoga used in curative group to cure the already formed kikkisa | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi , Reference: Charak Samhita Sutrasthana, Dravyaguna vidnyana Acharya Priyavat Sharma , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Manjishtadi Lotion is an Anubhuta Yoga, used for Preventive group for prevention of Kikkisa |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Primi-gravida with gestational age between 16th to 24th week and having no any symptoms of Kikkisa for Preventive Group.
2.Primi-gravida with gestational age between 20th to 28th week and having one or more symptoms or clinical features of Kikkisa for Curative Group.
3.Age 18-35 years primi-gravida. |
|
| ExclusionCriteria |
| Details |
1.Multi-gravida.
2.Polyhydramnios and Twin pregnancy
3.Pregnancy with huge uterine fibroid or ovarian cyst.
4.Pregnant woman suffering from any other skin disease.
5.Pregnant woman suffering from any systemic illness.
6.Pregnant woman above 40 years of age. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Group A for prevention of Straie Gravidarum
Group B to cure Straie Gravidarum |
Group A will be assessed for 8 weeks (treatment duration 16th to 24th week of pregnancy) Group B will be assessed for 8 weeks (treatment duration 20th to 28th week of pregnancy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Group A Striae Gravidarum does not appear at all
Group B Cure of the Striae Gravidarum & reduction in the symptoms kandu daha twaka bheda vaivarnya Rekha swaroop twaka sankocha
|
Group A 8 weeks of local application is sufficient to prevent Striae Gravidarum
Group B 8 weeks of local application is sufficient to cure the Striae Gravidarum |
|
|
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)
|
06/07/2025 |
| 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
|
The Present Title "An open labelled clinical trial on preventive and curative effect of Manjishtadi Lotion on Kikkisa w.s.r. to Striae Gravidarum" is a clinical study with total number of 40 registered Primi-gravida divided into 2 groups each 20. Group A will have 20 Primi-gravida in their 5th and 6th month of pregnancy and Group B will have 20 in their 6th and 7th month of pregnancy. Group A will be Preventive group and Group B will be Curative group. Both groups will be administered with local application of Manjishtadi Lotion on abdomen thrice a day for two months. Assessment will be done with subjective and objective criteria on 30th and 60th day. Follow up will be on 90th day. |