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临床试验/CTRI/2025/04/084120
CTRI/2025/04/084120尚未招募2 期

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 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To cure the development of strech marks over abdomen.

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 42.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

  • 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).

结局指标

主要结局

To cure the development of strech marks over abdomen.

时间窗: To baseline, 30th day,60th day, 90th day.

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

时间窗: To baseline, 30th day,60th day, 90th day.

次要结局

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

研究者

发起方
Parul Institute of Ayurved,Parul University,,Limda,waghodia, vadodara,Gujrat,India 391760
申办方类型
Research institution and hospital

研究点 (1)

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