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Clinical Trials/CTRI/2025/04/084120
CTRI/2025/04/084120Not yet recruitingPhase 2

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.

Parul Institute of Ayurved,Parul University,,Limda,waghodia, vadodara,Gujrat,India 3917601 site in 1 country50 target enrollmentStarted: April 18, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
To cure the development of strech marks over abdomen.

Study Overview

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.

Kikkisacan 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 careand Karveer taila in the Management  of KikkisaW.S.R to striae gravidarum.

OBJECTIVES

To evaluate the efficacy of application of STRIAE CAREin the Management of KikkisaW.S.R to striae gravidarum.

To compare the efficacy of application of STRIAE CARE & KARAVEER TAILAin the Management of KikkisaW.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 CAREis as effective as KARAVEER TAILAin the Management of KIKKISA.

Alternate Hypothesis (H2):  Application of STRIAE CARE is more effective thanKARAVEER TAILAin the Management of KIKKISA.

RESEARCH QUESTION:

IsSTRIAE CAREapplication is effective in the  Management of KIKKISAW.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

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 42.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Primigravida.
  • 23-30 weeks of pregnancy.
  • Age-18-42 years.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

To cure the development of strech marks over abdomen.

Time Frame: To baseline, 30th day,60th day, 90th day.

To observe the relief in itching and burning over the abdomen.

Time Frame: To baseline, 30th day,60th day, 90th day.

Secondary Outcomes

  • To cure the development of strech marks over abdomen.(To observe the relief in itching and burning over the abdomen.)

Investigators

Sponsor
Parul Institute of Ayurved,Parul University,,Limda,waghodia, vadodara,Gujrat,India 391760
Sponsor Class
Research institution and hospital

Study Sites (1)

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