CTRI/2024/06/068398Not yet recruitingPhase 2/3
A single arm clinical study to evaluate the efficacy of sitamishrit dhatriras in pittaj yonivyapad
Dr. Pallavi Nakhate1 site in 1 country35 target enrollmentStarted: June 20, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Effect of sitamishrit dhatriras in pittaj yonivyapad which will be assesed by the symptoms yonidaha (burning sensation at vulval region), and adhik raj straav (heavy menstrual bleeding)
Study Overview
Brief Summary
This is a single arm clinical study. The aim of this study is evaluate the efficacy of sitamishrit dhatriras in pittaj yonivyapad. Total 35 patients will be enrolled and 20 ml swaras will be given twice a day after meal for 15 days .The age group taken for study is 20 to 45 years women. The final conclusion will be drawn on the the basis of statistical methods.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Married woman, non pregnant women, age group between 20-45 years, patients with lakshana of pittaj yonivyapad- yonidaha(burning sensation at vulval region), adhik raj straav(heavy menstrual bleeding).
Exclusion Criteria
- •Sutika, history of Diabetes mellitus, hypertension, asthama, known case of cervical cancer, sexually transmitted diseases.
Outcomes
Primary Outcomes
Effect of sitamishrit dhatriras in pittaj yonivyapad which will be assesed by the symptoms yonidaha (burning sensation at vulval region), and adhik raj straav (heavy menstrual bleeding)
Time Frame: 14 days study with follow up on 7th , 14th day
Secondary Outcomes
- To observe th adverse effect of sitamishrit dhatriras(14 days study with follow up on 7th , 14th day)
Investigators
Dr Pallavi Nakhate
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune
Study Sites (1)
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