CTRI/2024/09/073489尚未招募Phase 3 4
Evaluation of comparative efficacy of external application of Varuna (Crataeva nurvala Buch-Ham) patra kalka with Ghrita after the Gomaya Gharsgana, Varuna patra Siddha Ghrita and Manjistha Ghrita in the management of Striae Gravidarum (Kikkisa): Three arm study
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月24日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To eliminate the Striae Gravidarum (Kikkisa) in Garbhani rog.
研究概览
简要总结
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divides into three group the trial is a randomized parallel arm clinical trial. It will include 8 weeks treatment period and follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Patient willing to participate with written informed consent.
- •Age group between 25-45 years.
- •2 years history of last delivery.
- •no prior treatment for Kikkisa before 1 month.
排除标准
- •pregnant women.
- •Lactating women.
- •Any type of skin disease other than Kikkisa.
- •Patient having chronic disease eg.
- •tuberculosis, jaundice etc
- •Any malignancy on the affected part was excluded.
结局指标
主要结局
To eliminate the Striae Gravidarum (Kikkisa) in Garbhani rog.
时间窗: 8 weeks
次要结局
- To assess the efficacy of Varuna Patra kalka with Ghrita after the Gomaya Gharshana, Varuna Patra Siddha Ghrita and Manjistha Ghrita in management of Garbhani rog (Kikkisa)(8 weeks)
研究者
Dr Pallavi Dewangan
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha
研究点 (1)
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