Randomised controlled clinical trial to evaluate the efficacy of guduchi ghanavati in the management of garbhini chardi with special reference to emesis gravidarum
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Aashitosh Suresh Desai
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Symptomatic relief of Garbhini Chardi within 1 week of treatment
Overview
Brief Summary
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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Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
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 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.
Outcomes
Primary Outcomes
Symptomatic relief of Garbhini Chardi within 1 week of treatment
Time Frame: 1 week
Secondary Outcomes
- Complete relief of garbhini chardi within 14 days(14 days)
Investigators
Dr Aashitosh Suresh Desai
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal nagar Hirawadi Panchavati Nashik