CTRI/2023/04/051304
Recruiting
未知
Single-arm clinical study to evaluate the analgesic effect of Trailokya Vijaya Vati Plus (Formulation femme) in Primary Dysmenorrhea.
Amrita School of Ayurveda0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: N944- Primary dysmenorrhea
- Sponsor
- Amrita School of Ayurveda
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects with regular menstrual periods lasting
- •21 to 35 days and menstruation lasting for 3 to
- •2\. Subjects who give consent for the study.
- •3\. Other causes of pain excluded using USG.
- •4\. Screened Subjects will be assessed by:Clinical
- •history and physical examination,
- •Haematological: Hb,ESR, CBC, Serum SGOT, SGPT \&
- •Serum BUN and Creatinine within 1\.5 times the
- •upper limit of normal range detected at
- •screening, Urine analysis and USG.
Exclusion Criteria
- •1\. Subjects having Dysmenorrhea secondary to
- •organic pathologies
- •2\. Subjects with irregular menstrual bleeding
- •3\. Subjects having a severe gynaecological illness
- •like uterine pathology fibroid adenomyosis
- •endometriosis etc
- •4\. Subjects with autoimmune diseases gynaecological Surgeries and genitourinary infections
- •5\. Subjects under hormonal therapy
- •6\. History or documentation of chronic illnesses
- •eg Diabetes hypertension Hypothyroidism bronchial asthma Gastroesophageal Reflux
Outcomes
Primary Outcomes
Not specified
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