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临床试验/CTRI/2024/04/066124
CTRI/2024/04/066124进行中(未招募)3 期

Effect of pre-conceptional ayurvedic protocol in the management of recurrent pregnancy loss in first trimester: a single arm open labelled clinical study

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
15
试验地点
1
主要终点
· To promote conception

研究概览

简要总结

INTRODUCTION

Recurrent pregnancy loss (RPL), also referred to as recurrent miscarriage or habitual abortion, is 2 or more consecutive pregnancy losses prior to 20 weeks from the last menstrual period. The incidence of RPL is increasing and its management is quite varied and challenging.  Management of RPL has to be revised as it requires intervention from Pre-conceptional period itself. Ayurveda gives great importance for the preconception care & Garbhini Paricharya, to ensure a healthy and successful progeny. The present protocol is selected ensuring both Shodhana and Shamana action through Virechana, Matra Basti, Uttara Basti and internal medication.

MATERIALS AND METHODS

In the present study, minimum 15 diagnosed patients of RPL fulfilling the selection criteria will be registered. Single group of the patients will be treated. In the first cycle *Deepana Pachana,*Snehapana, Sarvanga Abhyanga & Swedana and Virechana Karma will be performed. In the second cycle Matra Basti with Sahacharadi Taila and Uttara Basti with Kashmari Kutaja Siddha Ghrutha in the third cycle will be performed. Prajasthapana Churna will be given orally in 2nd& 3rd menstrual cycles after the  completion of Basti in both cycles.

RESULTS AND DISCUSSION

Data generated during the above study will be presented in a systemic methodical manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study, Pharmacological study will be discussed.

FOLLOW UP

Patients will be advised to visit the hospital weekly during treatment. Follow up will be done every 15 days for 2 months after the completion of intervention in every patient. If the patient conceives, follow up will be done for 3 months (during first trimester of pregnancy). After the conception routine Garbhini Paricharya as advised in regular  PTSR OPD including checkups, medicines (Bala+Shatavari +Guduchi +Brahmi +Nagkeshara each 1gm morning –evening before food with luke warm milk) USG and laboratory tests will be advised.

SIDE EFFECTS

These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. 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
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Married females of age between 19 – 40 years having history of two or more consecutive spontaneous abortion in first trimester with or without children.
  • Patients will be included minimum after 2 months of last abortion.

排除标准

  • · Patient with infectious diseases of reproductive tract like tuberculosis, sexually transmitted diseases, acute PID.
  • · Organic lesions of reproductive tract like fibroid uterus,carcinoma and congenital malformation of reproductive tract.
  • · Patients with history of cardiac diseases, Chronic liver disease, Uncontrolled Diabetes (≥160 mg/dl- FBS) & Hypertension (Systolic BP ≥160 & Diastolic ≥100 mmHg), TB, etc · Patient with Hepatitis C, Hepatitis B, HIV · Patient not eligible for Virechana Karma, Matra BastiandUttara Basti.

结局指标

主要结局

· To promote conception

时间窗: 6-7 months

· To prevent abortion in first trimester

时间窗: 6-7 months

次要结局

  • · To improve endometrial thickness.(· To increase luteal phase length in patients with short luteal phase.)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mufeena Jafar

Institute of Teaching and Research in Ayurveda, Jamnagar

研究点 (1)

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