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A study to evaluate the effect of Vishwaeladi Churna in Excessive menstrual bleeding.

Phase 2
Conditions
Health Condition 1: N920- Excessive and frequent menstruation with regular cycle
Registration Number
CTRI/2024/07/071261
Lead Sponsor
Dr Anusha Purohit
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Subjects with the age group of 18-45 years

2. Subjects irrespective of their marital status, religion and socio-economic status.

3. Subjects with cardinal symptoms of Asrugdara- a) Excessive blood loss during menstruation and/or b)Prolonged blood loss during menstruation.

4. Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excessive in amount or duration.

5. Subjects willing to do self-assessment/Pictorial Blood Assessment Chart.

6. Subjects after 3 months of removal of Intra uterine contraceptive device.

7. 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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. <br/ ><br>2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. <br/ ><br>Timepoint: 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. <br/ ><br>2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. <br/ ><br>Study Duration: <br/ ><br>Treatment Period -2 consecutive cycles <br/ ><br>Duration of Study Period- 3 consecutive cycles <br/ ><br> <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.Generation of in - depth analysed data on the different aspect of the disease. <br/ ><br>2.Generation of data on possible unexpected drug reaction. <br/ ><br> <br/ ><br>Timepoint: 1.Significant decrease in excessive blood loss & prolonged blood loss during menstruation, associated with pain & body ache assessed based on PBAC Scoring System , subjective & objective parameters. <br/ ><br>2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. <br/ ><br>Study Duration: <br/ ><br>Treatment Period -2 consecutive cycles <br/ ><br>Duration of Study Period- 3 consecutive cycles <br/ ><br> <br/ ><br>
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