| CTRI Number |
CTRI/2025/04/084120 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Management] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Stretch Mark management cream during pregnancy. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Applicaction Of Striae Care And Karveer Taila In The Management Of 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 Hani Patel |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 304,Department of Prasuti tantra Evum Stree Roga Parul Institute Of Ayurved Parul university Limda,Waghodia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9978946325 |
| Fax |
|
| Email |
hanipatel190397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 304,Department of Prasuti tantra Evum Stree Roga Parul Institute Of Ayurved Parul university Limda,Waghodia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
|
| Email |
ritamakim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rita Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 304,Department of Prasuti tantra Evum Stree Roga Parul Institute Of Ayurved Parul university Limda,Waghodia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
|
| Email |
ritamakim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved,Parul University,Limda,Waghodia,Vadodara,Gujrat,India 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved,Parul University,,Limda,waghodia, vadodara,Gujrat,India 391760 |
| Address |
Parul Institute of Ayurved Department of Prasuti Tantra Evum Stree Roga,3rd floor,Parul University.
limda,vadodara,gujarat,India 391760 |
| Type of Sponsor |
Research institution and 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 Hani Patel |
Parul Ayurved Hospital |
OPD No: 104 Department of stree roga and prasuti tantra,Parul Ayurved Hospital,Parul University,Limda ,Waghodia,Vadodara
Vadodara
GUJARAT |
9978946325
hanipatel190397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Parul Institute of Ayurved |
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: KIKKISA-GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Striae care, Reference: Astanga Samgraha, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karveer taila, Reference: Caraka Samhita, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida.
23-30 weeks of pregnancy.
Age-18-42 years. |
|
| ExclusionCriteria |
| Details |
Pt not willing for trail.
1st trimester of pregnancy.
Other skin diseases(atopic dermatitis,psoriasis,vitiligo),twin pregnancy,polyhydramnios.
Obesity (stretch marks due to obesity) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To cure the development of strech marks over abdomen.
To observe the relief in itching and burning over the abdomen. |
To baseline, 30th day,60th day, 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To cure the development of strech marks over abdomen.
To observe the relief in itching and burning over the abdomen. |
To baseline, 30th day,60th day, 90th day. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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
|
INTRODUCTION
Striae Gravidarum, or stretch marks, are a common dermatological concern, particularly during pregnancy, often causing emotional and physical discomfort. The condition, referred to as Kikkisa in Ayurvedic texts, is characterized by the appearance of linear scars on the skin, commonly on the abdomen, thighs, and breasts. The current study aims to evaluate and compare the efficacy of two treatments: Striae Care, a topical solution formulated for reducing stretch marks, and Karveer Taila, an Ayurvedic oil known for its skin-healing properties. This randomized comparative clinical study seeks to assess their effectiveness in managing Kikkisa, offering insights into potential therapeutic options. Kikkisa can be correlated with Striae gravidarum from modern point of view. The etiopathogenesis involves a combination of genetic factors, hormonal factors, and increased mechanical stress on connective tissue.The endocrine, metabolic, and immunological changes that take place during pregnancy result in various inherent skin transformations, one of which is the occurrence of Kikkisa.
NEED OF STUDY Studying striae Gravidarum from a cosmetic perspective can help individuals better understand and manage these change leading to improved self-confidence during and after pregnancy. Stretch marks are not an illness but many women are upset by appearance of such marks during pregnancy especially due to its cosmetic nuisance. Striae Gravidarum may compound this stress for some women, negatively affecting their psychological and emotional wellness. In conclusion, the study of striae gravidarum from both cosmetic and psychological perspectives is important for developing effective strategies for prevention and treatment, promoting body positivity, and supporting the emotional well-being of pregnant women. This research can contribute to both the cosmetic industry and the healthcare sector, ultimately benefiting the physical and mental health of individuals experiencing these skin changes.
AIM To study the comparative effect of ayurvedic formulation Striae care and Karveer taila in the Management of Kikkisa W.S.R to striae gravidarum.
OBJECTIVES To evaluate the efficacy of application of STRIAE CARE in the Management of Kikkisa W.S.R to striae gravidarum. To compare the efficacy of application of STRIAE CARE & KARAVEER TAILA in the Management of Kikkisa W.S.R to striae gravidarum. To Study the Concept of kikkisa and Striae gravidarum. HYPOTHESIS: Null Hypothesis (H0): There is no effect of application of STRIAE CARE in the Management of KIKKISA. Alternate Hypothesis (H1): Application STRIAE CARE is as effective as KARAVEER TAILA in the Management of KIKKISA. Alternate Hypothesis (H2): Application of STRIAE CARE is more effective than KARAVEER TAILA in the Management of KIKKISA.
RESEARCH QUESTION: Is STRIAE CARE application is effective in the Management of KIKKISA W.S.R to striae gravidrum?
METHOD OF COLLECTION OF DATA: sample size- 50 patient will be randomly allocated in two group Group-A Trial group of 25 patients– local application of STRIAE CARE. Group-B Control group of 25 patients– local application of KARVEERA TAILA. DIAGNOSTIC CRITERIA: Diagnosis will make on the basis of cardinal sign and symptoms i.e kandu vidaha , rekhaswaruptwaksamkocha. ASSESMENT OF CRITERIA: Subjective parameters: Kandu, Vidaha. Objective parameters: Rekha swarupa twak sankocha Length of most prominent RSTS Number of kikkisa
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