A Randomized open-labelled controlled clinical study to evaluate the efficacy of Vishwaeladi Churna in the management Of Asrugdara with special reference to Menorrhagia
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
Study Overview
Brief Summary
• Menorrhagia is defined as cyclic bleeding at normal intervals; the bleeding is either excessive in amount (>80ml) or duration (>7days) or both .
• It is largely responsible for iron deficiency anaemia which has negative effects on women health. It is considered to be one of the most significant causes of ill health in women.
• Menorrhagia has significant effects on personal, social, family and work life of women thereby reducing their quality of life. It significantly lowers the quality of life for women by having an impact on their personal, social, family, and work lives.
• The condition depends largely on hormonal therapy, prostaglandin inhibitors and anti-fibrinolytic drugs which causes adverse affects like nausea, vomitting, GI disturbances, liver diseases etc. They provide only symptomatic relief without providing any definite efficacy in long term.
• Vishwaeladi Churna is explained in Sahasrayoga, Churna Prakarana.
• “Vishwaelakanamusali Gokshuravamshisita Arajastadvat
RaktasravaprashamakamPaanarthambhishajaermatam.â€
(Sahasrayoga,ChurnaPrakarana)
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Subjects with the age group of 18-45 years
- •Subjects irrespective of their marital status, religion and socio-economic status.
- •Subjects with cardinal symptoms of Asrugdara- a) Excessive blood loss during menstruation and/or b)Prolonged blood loss during menstruation.
- •Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excessive in amount or duration.
- •Subjects willing to do self-assessment/Pictorial Blood Assessment Chart.
- •Subjects after 3 months of removal of Intra uterine contraceptive device.
- •Subjects willing to sign the consent form.
Exclusion Criteria
- •Subjects between the age group of 18-45 years. Subjects irrespective of their marital status, religion and socio-economic status. Subjects with cardinal symptoms of Asrugdara.
- •a) Excessive blood loss during menstruation and/or b) Prolonged blood loss during menstruation. Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excess in amount or duration. Subjects willing to do self assessment / Pictorial Blood Assessment Chart. Subjects willing to sign the consent form.
Outcomes
Primary Outcomes
1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
Time Frame: 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters. | 2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. | Study Duration: | Treatment Period -2 consecutive cycles | Duration of Study Period- 3 consecutive cycles
2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia.
Time Frame: 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters. | 2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. | Study Duration: | Treatment Period -2 consecutive cycles | Duration of Study Period- 3 consecutive cycles
Secondary Outcomes
- 1.Generation of in - depth analysed data on the different aspect of the disease.(2.Generation of data on possible unexpected drug reaction.)
Investigators
Dr Anusha Purohit
Sri Sri College of Ayurvedic Science and Research Hospital