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

A Randomized open-labelled controlled clinical study to evaluate the efficacy of Vishwaeladi Churna in the management Of Asrugdara with special reference to Menorrhagia - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071261

Enrollment

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N920- Excessive and frequent menstruation with regular cycle

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	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. 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. 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	—

Measure

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. 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. 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

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Secondary

Measure	Time frame
1.Generation of in - depth analysed data on the different aspect of the disease. 2.Generation of data on possible unexpected drug reaction. 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. 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	—

Measure

Time frame

1.Generation of in - depth analysed data on the different aspect of the disease. 2.Generation of data on possible unexpected drug reaction. 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. 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

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Countries

India

Contacts

Public ContactDr Anusha Purohit

Sri Sri College of Ayurvedic Science and Research Hospital

shrutivinsun@gmail.com9886269111

Outcome results