Randomised controlled clinical trial to evaluate the efficacy of guduchi ghanavati in the management of garbhini chardi with special reference to emesis gravidarum
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Symptomatic relief of Garbhini Chardi within 1 week of treatment
研究概览
简要总结
Randomised controlled clinical trial to evaluate the efficacy of guduchi ghanavati in the management of garbhini chardi with special reference to emesis gravidarum
Primary objective
To compare effect of guduchi ghanavati in garbhini chardi on comparison with doxylamine succinate
Secondary objective
To study the efficacy of guduchi ghanavati in garbhini chardi with special reference to emesis gravidarum
To study the disease garbhini chardi according to ayurveda and modern science
Literary review regarding guduchi
Patients will be divided in two groups
Group A and Group B and will be given guduchi ghanavati
and doxylamine succinate respectively for 14 days
Clinical assessment will be done on day 1 day 5 day 7 day 14
Inclusion criteria
Patients between 21 to 35 years of age
Patients diagnosed as garbhini chardi in first trimester of pregnancy
Patients with HB more than 8 gm per dl
Exclusion criteria
Pregnancy with convulsive disorder and fetal anomalies
Pregnant women suffering from communicable disease hypertension cardiovascular disease asthma severe gastrointestinal infections tuberculosis and serological disorder
Pregnant women suffering from multiple pregnancy ectopic pregnancy
Gynecological conditions like fibroids torsion of ovarian cyst and septic abortion with peritonitis
Uncooperative pregnant patients
Severe anemia
Pregnancy cholestasis
Withdrawal criteria
If found adverse effect or reaction
Patient not completing duration of treatment
Occurrence of any other disease during treatment
Primary outcome
Symptomatic relief of garbhini chardi within 7 days of start of treatment
Secondary outcome
Complete relief of garbhini chardi within 14 days of treatment
All data will be collected from clinical case studies will be presented in the form of graph charts grade
Patients will be observed before and after treatment
All observed data collected after the final assessment will be subjected to statistical analysis
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients between 21 to 35 years of age Patients diagnosed as garbhini chardi in first trimester of pregnancy Patients with Hb more than 8 gm per dl.
排除标准
- •Pregnancy with convulsive disorder and fetal anomalies Pregnant women suffering from communicable disease hypertension cardio vascular disease asthma severe gastrointestinal infections tuberculosis and serological disorders Pregnant women suffering from multiple pregnancy ectopic pregnancy Gynecological conditions like fibroids torsion of ovarian cyst and septic abortion with peritonitis Uncooperative pregnant patients Severe anemia Pregnancy cholestasis.
结局指标
主要结局
Symptomatic relief of Garbhini Chardi within 1 week of treatment
时间窗: 1 week
次要结局
- Complete relief of garbhini chardi within 14 days(14 days)
研究者
Dr Aashitosh Suresh Desai
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik