MANAGEMENT OF FIRST TRIMESTER OF PREGNANCY WITH AYURVEDIC RASAYANA THERAPY AND MICRONIZED PROGESTERONE.

Phase 3

Not yet recruiting

• Conditions: Supervision of pregnancy with other poor reproductive or obstetric history,

• Registration Number: CTRI/2020/12/030135
• Lead Sponsor: IPGT AND RA

Brief Summary

**INTRODUCTION**:Pregnancy means the beginning ofa new stage in a women’s life, with all the changes that a new stage can bring.This, 9 months period of pregnancy is clinically divided in to threetrimesters. 1st trimester is most crucial period for embryo thatneeds high qualitative micronutrient for development. The main complicationseen during first trimester of pregnancy is abortion which has various causeslike genetic factor, endocrinal factors, infections like TORCH, immunologicalfactors, maternal systemic disease like hypertension, severe anaemia etc. Goodquality antenatal care is one of the most effective ways to prevent pregnancycomplications both in mother as well as foetus. Forcontinuation of pregnancy manyhormonal drugs are given in modern practice. One of them is micronized progesterone. A recent study of progesteronesupplements found that they did not result in improved pregnancy outcomes andhave some side effects too. There is a great scope of research to findout safe, potent, less costly and effective remedies from *Ayurveda* forthe management of ailments and complications in 1st trimester ofpregnancy*.* So, here an effort in this direction has been put by thisresearch work. Keeping these points in view, *Rasayana*granules a combination of 8 *Rasayana* drugs are selected to see itsefficacy and action on women in first trimester of pregnancy.

In *Ayurveda,Acharya Charaka* defined *Rasayana* as a therapy used to form all the *Dhatus* properly. *Rasayana* not only provides longer, healthierlife but also helps to prevent some of the dreadful diseases. It is the uniquetherapy which provides qualitative micronutrients to both fetus and mother forhealthy progeny. We willregister 40 married females, having delayed Mc with UPT +vebetween 6-8 weeks of pregnancy. Ultrasonography showing gestational sac withfetal pole and presence of cardiac activity. Age from 20-40 years. Patients willbe divided in two groups by computer randomization. **INTERVENTION:** One group of the patientswill be treated with *Rasayana* granules*.* Another group of the patients will be treated with micronizedprogesterone. *Rasayana* granules willbe given orally in the dose of 10gm twice a day with *Godugdha* in morning & evening time in emptystomach for 2 months. micronized progesterone will be givenby orally in the dose of 200 mg of 1 tablet 2 times in morning andevening after meal with water for 2months. **FOLLOW UP**: Patients will be advised to visit thehospital every week during the treatment and at 5th month ofpregnancy after the treatment as follow up. In first meeting, Blood sample is to be takenfor examination. Early morning first urine sample is to be taken approx. 10 mlfor routine and microscopic examination. Both collections will be repeated atthe end of study also. USG reports will be done before treatment in first visit, at 5th month ofpregnancy(18-20 weeks), USG may be repeated in between the trial, if necessarydepending on patient’s condition. All the outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-29
• Study Start: 2021-04-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 1.Married females of age between 20.
• 40 years in first trimester of pregnancy having Hb > 7gm/dl. 2.Pregnancy confirmed by urine pregnancy test and ultrasonography. 3.All the UPT +ve cases between 6-8 weeks of pregnancy with or without these conditions:Primigravida/ multigravida with BOH, pregnancy after infertility, H/o threatened abortion, H/o habitual abortion, H/o blighted ovum, delayed fetal pole development, choriodecidual hemorrhage, IUFD, still birth, congenital deformity, previous preterm birth.

Exclusion Criteria

• 1.Married females of age < 20 years and >40 years age in first trimester of pregnancy.
• 2.Women in 2nd trimester or more trimester of pregnancy.
• Multigravida without BOH.
• 3.Womenwithseveresystemicdisease.
• 4.Diagnosed cases of disorders of reproductive tract like tuberculosis, carcinoma, and uterine fibroid and STDs. Incompetent Os and congenital deformities of uterus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that the trial drug will help in achieving healthy progeny without any trouble shooting	9-12 WEEKS AND 20 WEEKS OF PREGNANCY

Secondary Outcome Measures

Name	Time	Method
Drug may have effect in reducing the minor ailments and complications of first trimester of pregnancy.	9-12 WEEKS AND 20 WEEKS OF PREGNANCY

Trial Locations

Locations (1)

PG HOSPITAL,IPGT AND RA; 🇮🇳 Jamnagar, GUJARAT, India

PG HOSPITAL,IPGT AND RA

🇮🇳Jamnagar, GUJARAT, India

PROF LAXMIPRIYA DEI

Principal investigator

09228198366

deilaxmipriya@yahoo.com