CTRI/2023/04/051304招募中Unknown
Single-arm clinical study to evaluate the analgesic effect of Trailokya Vijaya Vati Plus (Formulation femme) in Primary Dysmenorrhea.
Amrita School of Ayurveda0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
- •Disease GERD atopic dermatitis celiac
- •disease or gluten sensitivity Crohns Disease
- •ulcerative colitis eating disorders breast
- •cancer a blood disorder
- •7. History of alcohol drug abuse or cigarette
- •8. Subjects participating in another investigational drug trial or had participated in one within 30 days of the start of the trial intervention
- •9. The subject participated in another investigational drug trial in the previous 30 days
- •10. Mentally retarded patients
- •11. Any other medical condition which in the
- •opinion of the investigator precludes the
- •inclusion of participant
研究者
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