Efficacy of Amarsundari vati and Chandanbala Lakshadi Taila Matra Basti in the management of Asrigdara A single arm clinical study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate the clinical efficacy of combination of Amarsundari vati with Chandanbala taila Matra basti for treating heavy and/ or prolonged menstrual bleeding or intermenstrual bleeding in terms of amount of menstrual blood loss in cases of Asrigdar (Menorrhagia)
研究概览
简要总结
Title: Efficacy of Amarsundari Vati and Chandanbala Lakshadi Taila Matra Basti in the Management of Asrigdara – A Single Arm Clinical Study
Scholar: Dr. Laxmi Devi, M.S. (Ayu.) Scholar, Department of Stri Roga and Prasuti Tantra, AIIA, New Delhi
Guide: Prof. Dr. Sujata Kadam Co-Guides: Dr. Swati Gaikwad, Dr. Tejaswini D. Buchade
**Overview:**This clinical study evaluates the combined efficacy of Amarsundari Vati (250 mg twice daily) and Chandanbala Lakshadi Taila Matra Basti (75 ml rectally for 7 days each month) in managing Asrigdara (Menorrhagia/Abnormal Uterine Bleeding).
Aim & Objectives:
- Primary: To assess the efficacy of the combined therapy in reducing heavy, prolonged, or intermenstrual bleeding.
- Secondary: To evaluate changes in endometrial thickness and hemoglobin levels.
Methodology:
- Study Type: Single arm, open-label clinical study
- Sample Size: 32 female patients aged 18–45 years
- Duration: 3 months treatment + 1 month follow-up
- Setting: OPD/IPD, Dept. of Stri Roga and Prasuti Tantra, AIIA
Assessment Parameters:
- Subjective: Duration and amount of bleeding, intermenstrual period, abdominal and back pain (graded scales).
- Objective: CBC, USG pelvis, hormonal and coagulation profiles, Hb levels.
**Expected Outcome:**The combination therapy is expected to significantly reduce menstrual blood loss, normalize cycles, and improve uterine health and anemia with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of reproductive age group 18-45years Patients with symptoms of heavy and prolonged menstrual bleeding or intermenstrual bleeding Patients willing for trial will be selected Patient with simple ovarian cyst.
排除标准
- •Patients with any diagnosed uterine organic pathology like Uterine Fibroid, ChronicTubo-ovarian mass.
- •Patients with coagulopathy, liver and thyroid dysfunction etc.
- •Patients with malignancy or undiagnosed neoplasm.
- •Patients with history of recent abortion.
- •Patients with active genital tuberculosis Pregnant and Lactating women.
- •IUCD in utero, pelvic endometriosis.
结局指标
主要结局
To evaluate the clinical efficacy of combination of Amarsundari vati with Chandanbala taila Matra basti for treating heavy and/ or prolonged menstrual bleeding or intermenstrual bleeding in terms of amount of menstrual blood loss in cases of Asrigdar (Menorrhagia)
时间窗: To evaluate the clinical efficacy of combination of Amarsundari vati with Chandanbala taila Matra basti for treating heavy and/ or prolonged menstrual bleeding or intermenstrual bleeding in terms of amount of menstrual blood loss in cases of Asrigdara (Menorrhagia)
次要结局
- To evaluate the clinical efficacy of the drug on the change in endometrial thickness & improvement in haemoglobin level(To evaluate the clinical efficacy of the drug on the change in endometrial thickness & improvement in haemoglobin level)
研究者
Dr Laxmi Devi
All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi