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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
2Comparator ArmDrugClassical(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
 
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.

 
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