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临床试验/CTRI/2025/09/095155
CTRI/2025/09/095155尚未招募不适用

Clinical Evaluation Of Amalaki Beeja Churna In Asrigdara W.S.R To Dysfunctional Uterine Bleeding

Rishikul Campus Haridwar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Reduction In Amount Of Heavy Bleeding

研究概览

简要总结

Asrigdara, described in Ayurvedic classics, correlates with Dysfunctional Uterine Bleeding (DUB), which is excessive or irregular uterine bleeding without identifiable organic pathology. It is a common gynecological disorder causing significant morbidity in women of reproductive age. Current management options often involve hormonal or surgical interventions with potential side effects, hence there is a need for safe, cost-effective alternatives.

Amalaki (Emblica officinalis) is a well-known Ayurvedic drug with Tridoshaghna, Rasayana, and haemostatic properties. Its seed powder (Amalaki Beeja Churna), rich in Vitamin C, tannins, and gallic acid, is traditionally indicated in bleeding disorders. This clinical trial aims to evaluate its efficacy in Asrigdara/DUB.

An open-label clinical study will be conducted on 30 female patients (16-45 years) diagnosed with Asrigdara/DUB attending OPD/IPD of Prasuti Tantra Evam Stree Roga. The intervention will be Amalaki Beeja Churna 6 g twice daily with honey and ghee for 3 consecutive menstrual cycles, with follow-up for 2 cycles.

Assessment will be based on subjective parameters (duration of bleeding, flow, pain, clots, associated symptoms) and objective parameters (Hb. blood loss, endometrial thickness).

This study aims to establish a safe, affordable herbal alternative for the management of Asrigdara/DUB.

研究设计

研究类型
Interventional

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Married and unmarried females Females having Chief complaint of excessive bleeding Per vaginum during menses either in amount or duration or both or during short inter menstrual period for 3 consecutive cycles Patients having normal BMI Hb more than 8 gm per dl.

排除标准

  • Patients having systemic diseases like Hypertension, Diabetes Mellitus, Tuberculosis, Thyroid dysfunction, Blood Coagulopathies Women of Penmenopausal & Postmenopausal age Pregnant women, Post partum females Patient having H/O recent Abortion Patient suffering from DUB complicated by non-responding Anemia Patient having organic pathology like Cervical or Uterine Polyp, Uterine Fibroids, PID Patients using OCP (Oral Contraceptive Pills), IUCD (Intra Uterine Contraceptive Device) or taking hormonal treatment.

结局指标

主要结局

Reduction In Amount Of Heavy Bleeding

时间窗: 2 Month

次要结局

  • Significant Improvement In Associated Symptoms Like Lower Backache & Generalised Weakness(1 Month)

研究者

发起方
Rishikul Campus Haridwar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Prof Dr G M Kavya

Rishikul Campus Haridwar

研究点 (1)

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