Efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally in the management of Vandhyatva (Female Infertility) due to anovulatory factor associated with obesity: A single arm open labelled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- It is expected that the trial protocol will induce ovulation.
研究概览
简要总结
**Introduction:The WHO defines infertility as ‘A disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse and there is no other reason, such as breastfeeding or postpartum amenorrhoea.’ The relationship between obesity and reproductive functions has been known for many years and it is still being explored. According to American Society for Reproductive Medicine (ASRM) obesity is the cause of fertility struggle in 6% of women who have never been pregnant before. In Sthaulya, thereis abnormal and excess accumulation of Medodhatu, where in only Medodhatu is nourished and other Dhatus are deprived of nourishment. According to AcharyaSushruta, Sthaulya is a Rasanimittaja Vikara and Artava being Upadhatu of Rasa Dhatu also gets affected and leads to anovulation and menstrual abnormality.
In this study, Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally has been included. Virechana is effective as it works as Srotoshodhana and Kaphahara. By Virechana Karma all Srotas especially Medovaha and Rasavaha Srotas gets purified. Matra Basti given through Guda (rectal route) normalizes Apana Vayu leading to Vatanulomana and physiological functioning of Vata, which may help in turn for the extrusion of ovum from the follicle and ovulation. Guduchi-Mustadi Kashaya contains Guduchi, Musta whichencounters Vata and Kapha Dosha by virtue of its Katu, Kashaya-Rasa dominance and Ushna-Veerya. Katu-Rasa performs Medo-Kledopa-Shoshana action. Triphala also having Meda-Kaphahara properties along with it enhances Agni.
AIM:
To evaluatethe efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orallyis effective in the management of female infertility due to anovulatory factor associated with obesity*.*
OBJECTIVES:
1. To assess the efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally on follicular growth and rupture of follicle.
2. To assess the efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally on BMI.
**Materials and Methods:**In the present study total 20 Clinically diagnosed and registered patients of Anovulation, fulfilling the criteria of inclusion will be registered. In 1st month, All the patients will be given Virechana Karma after the cessation of menstruation. In 2nd-3rd month Matra Basti with Lashunadi Taila 7days, after cessation of menses for 2 consecutive cycles along with Guduchi-Mustadi Kashaya (40ml) orally twice a day, before meal will be given.
**Results and Discussion:**Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.
**Side Effects:**This drug has no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients willing to give written informed consent by themselves. Infertile female patients of reproductive age more than or equal to 20 years and less than or equal to 40 years. Patients who have age less than 35 years completed active married life of minimum 1 year duration and patients aged 35 years or more completed active married life of 6 months suffering from Infertility with 2 or more consecutive anovulatory cycles. Patients having class I obesity.
- •overweight (BMI 25.0-29.9 kg/m2), class II obesity.
- •obesity (BMI 30.0-39.9 kg/m2). Primary and secondary infertile patients having anovulatory cycle or immature ovarian follicle. Patient eligible & willing for Virechana Karma and Matra Basti.
排除标准
- •Patients with infectious diseases of the reproductive tract like tuberculosis and sexually transmitted diseases.
- •Organic lesions of the reproductive tract like carcinoma and congenital deformities.
- •Patients with history of cardiac diseases, Uncontrolled Diabetes (above 200 mg/dl- RBS) & Hypertension (Systolic BP above 160 & Diastolic above 100mmhg), etc.
- •Patients with Hepatitis C, Hepatitis B.
- •Patients are not eligible for Virechana Karma and Matra Basti.
结局指标
主要结局
It is expected that the trial protocol will induce ovulation.
时间窗: 3 months
It is expected that trial protocol will help to reduce the BMI of patient.
时间窗: 3 months
次要结局
- Trial protocol will cure menstrual abnormalities associated with anovulation like irregular, scanty/ excessive menstruation and dysmenorrhea.(Improvement in quality of life.)
研究者
Alifeeya Mohammad Hussain Vaghela
Institute of Teaching and Research in Ayurveda, Jamnagar