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临床试验/CTRI/2025/09/094437
CTRI/2025/09/094437尚未招募不适用

Efficacy Of Virechana And Oral Dooshivishari Agada In Garbhasravi Vandhyatva Recurrent Pregnancy Loss A Single Arm Interventional Study

ALL INDIA INSTITUTE OF AYURVEDA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Increasing incidence of successful conception in patients with pregnancy loss during treatment and successful sustaining of pregnancy till First Trimester with the three month followup period

研究概览

简要总结

RESEARCH QUESTIONWhat is the impact of Virechana with Trivrit Avaleha, Dooshivishari Agada orally on conception and pregnancy continuation in Garbhasravi VandhyatvaRecurrent Pregnancy Loss in First Trimester

NULL HYPOTHESISThe administration of Virechana with Trivrit Avaleha, oral administration of Dooshivishari Agada 500 mg 2 tablets BD for 3 months has no significant effect on conception and pregnancy continuation in women diagnosed with Garbhasravi Vandhyatva Recurrent Pregnancy Lossin First Trimester

ALTERNATE HYPOTHESISThe administration of Virechana with Trivrit Avaleha, oral administration of Dooshivishari Agada 500 mg 2 tablets BD for 3 months  hassignificant effect on conception and pregnancy continuation in women diagnosed with Garbhasravi Vandhyatva  Recurrent Pregnancy Loss in First Trimester

Need of the StudyRecurrent Pregnancy Loss affects 2percent–5percent of couples and remains unexplained in nearly 50percent of cases Current modern medical approaches such as hormonal therapy, anticoagulants, and surgery often fail to provide satisfactory outcomes in these unexplained cases Ayurveda offers holistic protocols like Virechana and oral Vishahara therapy Dooshivishari Agada which are traditionally used to detoxify the body improve uterine health and enhance fertility However there is a lack of clinical evidence supporting their efficacy in RPL This study aims to bridge that gap by scientifically evaluating Ayurvedic protocols using modern diagnostic tools and outcome measures

OBJECTIVES To evaluate the efficacy of Virechana Dooshivishari Agada improving conception rates and pregnancy continuation in women with Garbhasravi Vandhyatva Recurrent Pregnancy Loss

PrimaryTo assess the efficacy of Virechana Dooshivishari Agadain enhancing conception rates and successful continuation of pregnancy till First Trimester among patients experiencing Garbhasravi Vandhyatva Recurrent Pregnancy Loss

SecondaryTo evaluate the therapeutic benefits of Virechana Dooshivishari Agada on Garbhasravi Vandhyatva Recurrent Pregnancy Loss in first trimester to improve reproductive health by restoring ovulatory function menstrual irregularities reproductive hormonal imbalance

Research Methodology

This is a single group prospective clinical interventional study Sample size will be 30 women with a history of recurrent pregnancy loss of more than or equals to 2 in the first trimester Eligible participants will receive Virechana using Trivrit Avaleha followed by oral administration of Dooshivishari Agada 500 mg 2 tablets twice daily for 3 months Patients will be recruited from the OPD of the Striroga Evam Prasuti Tantra department at AIIA Sarita Vihar

Follow up study will be conducted for either three cycles after completion of the treatment or till the sustainability of first trimester of pregnancy

If patient got conceived then the routine antenatal care will be followed

end point will be uneventfull completion of first trimester of pregnancy

Inclusion Criteria

Married females aged 20 to 40 years

History of two or more first-trimester pregnancy losses

Willingness to participate and provide informed consent

Normal semen analysis of the husband

Fit for Virechana therapy

Exclusion Criteria

Chronic systemic illnesses such as diabetes hypertension HIV hepatitis B or STDs

Uncontrolled thyroid disorders

Anatomical abnormalities in the reproductive tract

TORCH IgM positive cases

Unfit for Virechana

Investigations to be Done

before and after treatment

USG pelvis and obstetrics

Transvaginal sonography for follicular study

Serum hormone profile Progesterone Estrogen FSH LH Prolactin

APLA profile quantitative

TORCH profile quantitative

CBC with ESR

LFT KFT

before treatment

Urine routine and microscopy

TB Gold

HSG

HIV 1 & 2 HBsAg Anti HCV VDRL

Husband semen analysis

thyroid profile

Assessment Criteria

Subjective Criteria

Sustaining of pregnancy through the first trimester

Menstrual parameters such as duration of bleeding cycle interval and flow during menstruation

Objective Criteria

Follicular development and ovulation via TVS

Endometrial thickness on day 14

Hormonal levels FSH LH estrogen progesterone prolactin

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Married female patients of child bearing age of 20 40 years Patients of secondary infertility having history of recurrent pregnancy loss more than or equals to 2 in first trimester Patients willing to enrol in the study Patients who are eligible for Virechana Patients with normal husband semen analysis.

排除标准

  • Patients suffering from any chronic debilitating disease like diabetes mellitus hypertension sexually transmitted disease hepatitis B and AIDS Uncontrolled hypothyroidism hyperthyroidism Patient having any anatomical defect in reproductive system Patients with positive TORCH IgM Patients who are not eligible for Virechana.

结局指标

主要结局

Increasing incidence of successful conception in patients with pregnancy loss during treatment and successful sustaining of pregnancy till First Trimester with the three month followup period

时间窗: Baseline | 3 Months | 6 Months

次要结局

  • The therapeutic integration of Virechana, Dooshivishari Agada is anticipated to improve reproductive health by restoring ovulatory function, menstrual irregularities, reproductive hormonal imbalance.(6months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

MUSKAN JAIN

All INDIA INSTITUTE OF AYURVEDA SARITA VIHAR NEW DELHI 110076

研究点 (1)

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