Efficacy Of Virechana And Oral Dooshivishari Agada In Garbhasravi Vandhyatva Recurrent Pregnancy Loss A Single Arm Interventional Study
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
MUSKAN JAIN
All INDIA INSTITUTE OF AYURVEDA SARITA VIHAR NEW DELHI 110076
