Randomized controlled clinical trial to study the efficacy of Punarnava churna vati in the management of Raktapradar with special reference to Menorrhagia
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Reduce Raja Praman Rajastrav avadhi Adhodar shool
Study Overview
Brief Summary
Randomized controlled clinical trial to study the efficacy of Punarnava churna vati in the management of Raktapradar with special reference to MenorrhagiaPrimary Objective
To study the efficacy of Punarnava churna vati with jala in Raktapradar with special reference to Menorrhagia
Secondary Objective
To study the disease Raktapradar according to Ayurveda and Modern literature of Menorrhagia
Literary review regarding Punarnava churna vati
To study the efficacy of Punarnava churna vati against Tranexamic acid
Material and Methods
Patients will be divided into two groups by simple randomized method as Group A and Group B as trial group and control group respectively wherein Group A will be given Punarnava churna vati with jala of dose vati of 500mg twice a day and Group B will be given Tab Tranexamic acid 500mg dose 1 tablet twice a day and follow up will be done on fifth seventh and tenth day of menses with assessment of lakshanas and clinical assessment will be done for three cycles that is two cycles with medication and third cycle without medication
Inclusion criteria
Patients between 18 and 40 years of age
Patients having excessive but cyclic menses of more than 7 days
Hemoglobin should be more than 8gm percent
Patients having bleeding in excessive amount by noting the number of pads used per day
Exclusion criteria
Non cooperative patients
Hemoglobin less than 8gm percent
USG showing retained products of conception and patient having a recent history of dilatation and curettage done or dilatation and evacuation done and history of threatened spontaneous or incomplete abortion within last 3 months
Withdrawal criteria
Patient leaving the treatment without completing the treatment course
If any adverse effects seen during the treatment
Any disease taken place during the treatment
Assessment criteria
Assessment of the patient will be done on the basis of raja pravritti kala raja praman raja varna generalized weakness assosciated with the ability to do daily routine activities abdominal pain and bodyache during heavy menses along with the consistency of the bloodflow
Patients will be selected as per inclusion and exclusion criteria along with well informed consent form filled by the patients accordingly and data will be collected using case record form and observation will be done in the form of tables and graphs
Results and inference will be drawn on the basis of the data obtained before and after treatment using statistical data and method
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patient having excessive but cyclic menses of more than 7 days Hemoglobin should be more than 8gm percent Patient having bleeding in excessive amount that is number of pads used.
Exclusion Criteria
- •Non cooperative patient Hemoglobin less than 8gm percent Patient with comorbidities like Diabetes mellitus Thyroidism Hypertension Patient with IUCD inserted USG showing retained products of conception Patient with recent history of dilatation and curettage threatened or spontaneous or incomplete abortion within last 3 months.
Outcomes
Primary Outcomes
Reduce Raja Praman Rajastrav avadhi Adhodar shool
Time Frame: 8 weeks
Secondary Outcomes
- To reduce Strava swaroop generalized weakness Bhrama accompanied with excessive raja strava(2 menstrual cycles)
Investigators
Dr Sonal Vijay Jaiswal
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik Kamal Nagar Panchvati Nashik 422003