| CTRI Number |
CTRI/2025/06/089431 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treating Stretch Mark Of Pregnancy By Chandanabalalakshadi Taila |
|
Scientific Title of Study
|
An Open Label Randomized Comparative Clinical Study to Know The Effect Of Chandanabalalakshadi Taila And Nalpamaradi Taila In The Prevention Of Garbhini Kikkisa Vis a Vis 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 Hemalatha HK |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical college and Hospital, Mysuru |
| Address |
Department of PG Studies in Prasooti tantra and stree roga.JSS Ayurveda Medical College and Hospital,Lalithadripuram road,alanhalli,Mysuru,Karnataka, Mysore KARNATAKA 570028 India
Mysore
KARNATAKA
570028
India |
| Phone |
7406321208 |
| Fax |
|
| Email |
hemalathakottur1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nanda K o |
| Designation |
Assistant professor |
| Affiliation |
JSS Ayurveda medical college and Hospital |
| Address |
Department of PG Studies in Prasooti tantra and stree roga.JSS Ayurveda Medical College and Hospital,Lalithadripuram road,alanhalli,Mysuru,Karnataka, Mysore KARNATAKA 570028 India
Mysore
KARNATAKA
570028
India |
| Phone |
8970322532 |
| Fax |
|
| Email |
nandadeepak.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanda K o |
| Designation |
Assistant professor |
| Affiliation |
JSS Ayurveda medical college and Hospital |
| Address |
Department of PG Studies in Prasooti tantra and stree roga.JSS Ayurveda Medical College and Hospital,Lalithadripuram road,alanhalli,Mysuru,Karnataka, Mysore KARNATAKA 570028 India
KARNATAKA
570028
India |
| Phone |
8970322532 |
| Fax |
|
| Email |
nandadeepak.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College And Hospital Lalithadripuram Road Mysuru Karnataka India 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Hemalatha H K |
| Address |
OPD NO 9 Department of PG Studies in Prasooti tantra and Stree roga ,JSS Ayurveda Medical College and Hospital,Lalithadripuram road alanahalli,Myusuru,Karnataka,
570028 India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Ayurveda Medical college and Hospital |
OPD NO.9 Department of PG Studies in Prasooti tantra and Stree roga,JSS Ayurveda Medical College and Hospital,Lalithadripuram road alanahalli,Myusuru,Karnataka, 570028 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemalatha HK |
JSS Ayurveda Medical College |
OPD NO.9 Department of PG Studies in Prasooti tantra and stree roga.JSS Ayurveda Medical College and Hospital,Lalithadripuram road,alanhalli,Mysuru,Karnataka, Mysore KARNATAKA 570028 India
Mysore
KARNATAKA |
7406321208
hemalathakottur1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L906||Striae atrophicae. Ayurveda Condition: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandanabala lakshadi taila, Reference: yogaratnakara jwaradhikara chapter 2 verse 483-490, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -External application | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nalpamaradi taila , Reference: sahasrayoga tailaprakara , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -External application |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primigravida 2nd to 3rd trimester with single gestation
2. Age group 20 to 35years |
|
| ExclusionCriteria |
| Details |
1. Multigravida
Previous surgical scar on abdomen
3. Pre existing skin disease like Eczema, Dermatitis, Psoriasis
4. Obesity BMI more than 30 at first visit
5. Hydramnios and twin pregnancy, known case of fibroid or ovarian cyst.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Chandanabala lakshadi Taila and Nalpamaradi Taila in the prevention of Garbhini Kikkisa |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Chandanabala lakshadi Taila in prevention of Garbhini Kikkisa
2. To evaluate the efficacy of Nalpamaradi Taila in prevention of Garbhini Kikkisa.
|
6 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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 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
|
Skin is considered as the mirror of human body as it reflects the physical,mental and emotional status of every person . Any derangement in external appearance of the skin becomes worrisome to a lady as it hampers her appearance and self confidence . Pregnancy is an important event in a women’s life and is one of the most precious experiences. However, it is also associated with many molimina which influence her physical and psychological well being. Kikkisa being one among them. This condition, included in Garbhini vyadhi presents with symptoms like kandu, vidaha, vaivarnyata and twak sankocha etc.,on the skin. The twak sankocha developed remains for the rest of her life and symptoms like kandu, vidaha etc may affect her daily routine activities based on their severity of manifestation during pregnancy. It can be correlates to the condition to the linear, depressed, atrophic, pinkish or purplish, scar like lesions with varying length and breadth called Striae gravidarum, which appear at the end of mid trimester of pregnancy. About 50% to 90% of women are affected with Striae gravidarum. Therefore, it has become important to manage this condition during pregnancy . There are several methods available today for managing stretch marks which involves invasive procedures like laser surgeries, dermabrasions, tummy tuck etc.As these treatments are expensive, the scope for conservative management is huge and need of the hour. Even the slightest scar can cause psychological stress in her, hence any measure which helps in this condition will be a boon for the women. As the Ayurveda says ‘Swasthasya Swasthya Rakshana’, prevention is better than cure hence the clinical study is planned to know the effect of CHANDANABALA LAKSHADI TAILA5 And NALAPAMRADI TAILA in the prevention of GARBHINI KIKKISA Vis-àvis Striae Gravidarum . The drug taken for this study is CHANDANABALA LAKSHADI TAILA and NALPAMARADI TAILA which has been indicated in Twak Vikara and also contains the drugs which acts as Kushtagna, Kandugna, Dahaprashamana, Varnya which prevents the kikkisa . |