CTRI/2024/05/067224
Not yet recruiting
Phase 2/3
A Single Arm Clinical Study To Evaluate The Efficacy Of Bhunimba Churna With Madhu In Garbhini Hrullas; Nausea In Pregnancy
DR Smruti Vijaykumar Honmute1 site in 1 country40 target enrollmentStarted: May 20, 2024Last updated:
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- DR Smruti Vijaykumar Honmute
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of Bhunimba Churna with Madhu in Garbhini Hrullas
Overview
Brief Summary
THIS IS SINGLE ARM CLINICAL STUDY .
THE AIM OF THE STUDY IS" TO EVALUATE THE EFFICACY OF BHUNIMBA CHURNA WITH MADHU IN GARBHINI HRULLAS (NAUSEA IN PREGNANCY)"
TOTAL 40 PATIENTS WILL BE ENROLLED AND 6 GRAMS BHUNIMBA CHURNA WILL BE GIVEN WITH EQUAL AMOUNT OF MADHU TWICE A DAY BEFORE MEAL.
THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE BETWEEN 21YEAR TO 40 YEAR .
AYURVEDIC FORMULATION WILL BE GIVEN ON 0TH ,7TH,14TH DAY AND TOTAL DURATION OF STUDY WILL BE 14 DAYS.
SUBJECTIVE AND OBJECTIVE CRITERIA WIIL BE STUDIED .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Both primigravida and multigravida 1st and 2nd trimester.
Exclusion Criteria
- •Molar pregnancy Pregnancy with severe vomiting Appendicitis Hepatitis Pancreatitis presenting with vomiting Pregnancy with severe dehydration.
Outcomes
Primary Outcomes
To evaluate the efficacy of Bhunimba Churna with Madhu in Garbhini Hrullas
Time Frame: 14 days study with follow up on 7th and 14th day
Secondary Outcomes
- To observe the adverse effect of Bhunima Churna with Madhu in Garbhini Hrullas(14 days study with follow up on 7th and 14th day)
Investigators
DrSmruti Vijaykumar Honmute
DR. D.Y. Patil College Of Ayurveda and Research Centre
Study Sites (1)
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