| CTRI Number |
CTRI/2026/01/102018 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on effect of application of Jeevanthyadi Yamak and Karaveera Patra Taila in the pregnancy stretch marks |
|
Scientific Title of Study
|
An Open-labeled Comparative Clinical Trial on the Efficacy of application of Jeevanthyadi Yamak and Karaveera Patra Taila in the Kikkisa (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 Hetal Chandragupt Vidhyadhar |
| Designation |
MS Ayurveda Scholar of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Shree swaminarayan Ayurvedic College, Kalol |
| Address |
Department of Prasuti Tantra Evum stree Roga Shree Swaminarayan Ayurvedic College Kalol Gandhinagar 382725 Shree Swaminarayan Ayurvedic College Opp Kalol GIDC Saij Ahmedabad Mehsana Highway Kalol Gandhinagar 382725 Gandhinagar GUJARAT 382725 India |
| Phone |
9484607397 |
| Fax |
|
| Email |
drhetalgchauhan784@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lumi Bhagat |
| Designation |
BAMS MS Ayu PhD Associate Professor Prasuti Tantra Evum Stree Roga |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Department of Prasuti Tantra Evum Stree Roga
Shree Swaminarayan Ayurvedic College
Opp Kalol GIDC Saij Kalol Ahmedabad Mehsana Highway Kalol Gandhinagar 382725 Opp Kalol GIDC Saij Kalol Ahmedabad Mehsana Highway Kalol Gandhinagar 382725 Gandhinagar GUJARAT 382725 India |
| Phone |
8319352370 |
| Fax |
|
| Email |
lumibhagat31@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lumi Bhagat |
| Designation |
BAMS MS Ayu PhD Associate Professor Prasuti Tantra Evum Stree Roga |
| Affiliation |
Shree Swaminarayan Ayurvedic College |
| Address |
Shree Swaminarayan Ayurvedic College
Opp Kalol GIDC Po Saij Ahmedbad Mehsana Highway Kalol Gandhinagar 382725 Shree Swaminarayan Ayurvedic College
Opp Kalol GIDC Po Saij Ahmedbad Mehsana Highway Kalol Gandhinagar 382725 Gandhinagar GUJARAT 382725 India |
| Phone |
8319352370 |
| Fax |
|
| Email |
lumibhagat31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1 OPD of prasuti Tantra Evum Stree Roga Shree Swaminarayan Ayurvedic Hospital kalol |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic College and Hospital |
| Address |
Opp Saij GIDC kalol Ahmedabad Mehsana Highway Kalol Gandhinagar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hetal Chandragupt Vidhyadhar |
Shree Swaminarayan Ayurvedic College and Hospital |
Room No 1 OPD of prasuti Tantra Evum Stree Roga Shree Swaminarayan Ayurvedic Hospital kalol Gandhinagar GUJARAT |
9484607397
drhetalgchauhan784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Swaminarayan Ayurvedic College Kalol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JEEVANTHYADI YAMAKA, Reference: As.Hr. Ni./4, As.Hr.Chi.19., Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: LOCAL APPLICATION OVER ABDOMEN TWICE A DAY | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KARAVEERA PATRA TAILA, Reference: As A.S.Sh.3.3/9, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: LOCAL APPLICATION OVER ABDOMEN TWICE A DAY |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient Willing For the Trial
Primigravida
16 To 20 Weeks of Pregnancy 4th Or 5th Month of Pregnancy
Multigravida with Previous Pregnancies Outcome as Abortion |
|
| ExclusionCriteria |
| Details |
Patient Not Willing For the Trial
1st Trimester of Pregnancy
Other Skin Diseases
Obesity
Old Scar |
|
|
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 Main Effect or Benefit That the Study Will Achieve |
Base Line to Till Delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Additional Benefits Observations or Data the Study May Reveal |
Base Line to Till Delivery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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="3" 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
|
Kikkisa is a common condition described in classical Ayurvedic texts, typically manifesting on the abdomen during the seventh month of pregnancy. The etiology of Kikkisa is attributed to the vitiation of the Tridosha (Vata, Pitta, and Kapha), primarily caused by the pressure and growth of the developing foetus. This doshic imbalance results in Vidaha (burning sensation) and Kandu (itching), which are the hallmark symptoms of the condition. Kikkisa predominantly affects areas of the body where skin undergoes extensive stretching—most notably the abdomen, but also the breasts and thighs. These marks may develop during late pregnancy and often persist in the postpartum period. The condition is closely comparable to Striae Gravidarum in modern medical terminology. Modern science recognizes several types of striae, among which striae gravidarum is the most commonly observed, especially during pregnancy. As gestation progresses, many women experience itching, redness, and rashes, particularly over the abdomen, which can interfere with their daily comfort and routine activities.This dermatological condition is often considered inevitable in a woman’s life due to the physiological changes of pregnancy. However, appropriate skin care and the use of preventive topical applications or medications can play a significant role in minimizing the severity and progression of striae gravidarum. Early intervention is key to maintaining skin elasticity and reducing discomfort during this period. Moreover it is imperative to avoid unnecessary chemicals during pregnancy as it may cause adverse effects to the foetus. Therefore Ayurveda can suggest an alternative choice of treatment with minimal side effects So, to prevent this disease, there is a need to develop a new cosmetic branch in Ayurvedic science. Even then Ayurvedic management and treatment is very beneficial for the natural skin and body care. This study was an effort to understand the disease according to Ayurvedic principles and evaluate the efficacy of Jeevanthyadi yamak & Karaveera Patra Siddha Taila in the prevention of kikkisa. Aim · To evaluate the efficacy of application of ayurvedic formulation in the Kikkisa W.S.R to striae gravidarum. Objectives– · To evaluate the efficacy of application of Jeevanthyadi yamak in the Kikkisa W.S.R to striae gravidarum. · To compare the efficacy of application of Jeevanthyadi yamak and Karaveera Patra Taila in the Kikkisa W.S.R to Striae gravidarum. Research Question: Is Jeevanthyadi yamak (in a roll on form) application effective in the KIKKISA W.S.R to Striae gravidarum ?
HYPOTHESIS: · Null Hypothesis (H0): There is no effect of application of Jeevanthyadi yamak in the KIKKISA. · Alternate Hypothesis (H1): Application of Jeevanthyadi yamak is as effective as Karaveera Patra Taila in the KIKKISA. · Alternate Hypothesis (H2): There is difference in the efficacy of application of Jeevanthyadi yamaka and Karaveera Patra Taila in the KIKKISA. |