“A Clinical Study to Evaluate the Efficacy of the Shirishadi Malhar & Parushakadi Yog in the Management of KIKKISA w.s.r. to STRIAE GRAVIDARUM"
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- overall symptomatic improvement will be assessed by applying Modified Atwal Score of striae gravidarum
研究概览
简要总结
Research report will be soon published after the completion of trial 200 patients fulfiling the Inclusion and exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga , RGGPG Ayurvedic College and Hospital , Paprola. Patients will be divided into two groups of 100 each .Study group I - Shirishadi Malhar for local application .Study group II - Shirishadi Malhar for local application & Parushakadi Yog orally.Duration of trial will be 2 months , Three follow ups .Patients will be followed up monthly for 2 months. 1st follow up after completion of 1 month of trial & 2nd follow up after completion of trial & last follow up after one month of drug free period. The patient treated in trial group will be assessed by presence or absence of signs and symptoms before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Period of pregnancy between 24-32 weeks.
- •2.Both Primi & multi gravida having classical sign & symptoms of Kikkisa w.s.r. to Striae Gravidarum.
排除标准
- •1.Age below 20 & above 40 yrs.
- •Any type of skin disease other than Kikkisa.
- •3.Associated Systemic diseases like Tuberculosis, Jaundice etc.
结局指标
主要结局
overall symptomatic improvement will be assessed by applying Modified Atwal Score of striae gravidarum
时间窗: 2 months
次要结局
- Establishment of Shirishadi Malhara & Parushakadi Yoga in the management of Kikkisa or Striae gravidarum(1-1/2 year)