A Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Artava Janana Effect of kashmarya- kshudrasaha granules in vataja artava dushti W.S.R. to Oligo-hypomenorrhoea on the basis of Pictoral Blood Assessment Chart, artava srava swaroopa chart, artava srava kalaavdhi chart, duration between two artava darshana both before and after treatment.
Study Overview
Brief Summary
This is a Single Arm Clinical Trial to Evaluate the Artava Janaka properties of Kashmarya Kshudrasaha Granules in the Management of Vataja Artava Dushti W.S.R to Oligohypomenorrhoea.
70 patients selected according to inclusion criteria will be administered with kashmarya-kshudrasaha granules orally mixed with milk twice a day in a single dose of 1 karsha (10g) for 3 menstrual cycles.
The Primary outcome measures will be improvement in the amount of menstrual bleeding & reducing the inter-menstrual duration. This will be assessed by subjective parameters i.e. Artava srava swaroopa (Appearance of menstrual blood),Artavasrava Kalaavadhi (Duration of Menstrual Flow) & Duration of Artava darshan (Interval between two cycles) and subjective parameter i.e. by comparing the changes in Pictorial Blood Chart before and after treatment. The total duration of the study is 18 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 13.00 Year(s) to 19.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •â€¢All female patients in the Age group of 13-19 years who are willing to participate in the study who are having symptoms of vataja artava dushti.
- •â€¢With symptoms of oligo-hypomenorrhea i.e. inter-menstrual duration more than 35 days and menstrual bleeding flow less than 2 days.
- •â€¢Female patients irrespective of caste, education, income group and any occupation will be selected.
- •â€¢Hemoglobin 9 g % and above.
- •â€¢BMI – 18-27.
Exclusion Criteria
- •â€¢K/C/O of any major systemic diseases.
- •â€¢K/H/O of Mullerian Duct Anomalies.
- •â€¢Intermenstrual duration more than 60 days.
Outcomes
Primary Outcomes
Artava Janana Effect of kashmarya- kshudrasaha granules in vataja artava dushti W.S.R. to Oligo-hypomenorrhoea on the basis of Pictoral Blood Assessment Chart, artava srava swaroopa chart, artava srava kalaavdhi chart, duration between two artava darshana both before and after treatment.
Time Frame: 3 menstrual cycles
Secondary Outcomes
- Improvement in Vataja artava dushti condition i.e. improving the amount of menstrual bleeding & reducing the inter-menstrual duration.(3 menstrual cycles)
Investigators
Meghna Vaman Nayak
Yashwant Ayurvedic College, Post Graduate Training and Research Centre