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Efficacy and safety of AYUSH SR in Premenstrual Syndrome

Phase 2
Conditions
Health Condition 1: N943- Premenstrual tension syndrome
Registration Number
CTRI/2024/07/071600
Lead Sponsor
Central Council For Research In Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

1.Female participants of reproductive age group (18-40) with regular menstrual cycle (between 21 and 35 days) having moderate symptoms as per PSST tool(Premenstrual Symptoms Screening Tool).

2.Symptoms should occur during the luteal phase.

3.Willing to participate in the study

Exclusion Criteria

1.Patients diagnosed with Uterine fibroids , polyps and congenital uterine anomalies.

2.Diagnosed patients with diabetes mellitus, poorly controlled Hypertension(Blood pressure more than 160/100 mm of Hg) or hormonal disorders.

3.Patients with concurrent hepatic disorderdefined as aspartate amino transferase and/or alanine amino transferase greater than 2 times the upper normal limit or renal disorders defined as serum Creatinine greater than the upper limit of laboratory value)

4.Patients who are undergoing any hormonal treatment or using contraceptive pills.

5.Psychiatric disorders and malignant conditions

6.Pregnant/lactating females.

7.Patients who have completed participation in any other clinical trial during the past six (06) months.

8.Any other condition that the Investigator thinks may jeopardize the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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