1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  FOR DESSERTATION WORK OF THE INSTITUTE


6. For how long will this data be available start date provided 04-05-2022 and end date provided 04-05-2025?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

INTRODUCTION:Pregnancy means the beginning of a 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 three trimesters. 1^st trimester is most crucial period for embryo that needs high qualitative micronutrient for development. The main complication seen during first trimester of pregnancy is abortion which has various causes like genetic factor, endocrinal factors, infections like TORCH, immunological factors, maternal systemic disease like hypertension, severe anaemia etc. Good quality antenatal care is one of the most effective ways to prevent pregnancy complications both in mother as well as foetus. For continuation of pregnancy many hormonal drugs are given in modern practice. One of them is micronized progesterone. A recent study of progesterone supplements found that they did not result in improved pregnancy outcomes and have some side effects too. There is a great scope of research to find out safe, potent, less costly and effective remedies from Ayurveda for the management of ailments and complications in 1^st trimester of pregnancy. So, here an effort in this direction has been put by this research work. Keeping these points in view, Rasayana granules a combination of 8 Rasayana drugs are selected to see its efficacy 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, healthier life but also helps to prevent some of the dreadful diseases. It is the unique therapy which provides qualitative micronutrients to both fetus and mother for healthy progeny. We will register 40 married females, having delayed Mc with UPT +ve between 6-8 weeks of pregnancy. Ultrasonography showing gestational sac with fetal pole and presence of cardiac activity. Age from 20-40 years. Patients will be divided in two groups by computer randomization. INTERVENTION: One group of the patients will be treated with Rasayana granules. Another group of the patients will be treated with micronized progesterone. Rasayana granules will be given orally in the dose of 10gm twice a day with Godugdha in morning & evening time in empty stomach for 2 months. micronized progesterone will be given by orally in the dose of 200 mg of 1 tablet 2 times in morning and evening after meal with water for 2 months. FOLLOW UP: Patients will be advised to visit the hospital every week during the treatment and at 5^th month of pregnancy after the treatment as follow up. In first meeting, Blood sample is to be taken for examination. Early morning first urine sample is to be taken approx. 10 ml for routine and microscopic examination. Both collections will be repeated at the end of study also. USG reports  will be done before treatment in first visit, at 5^th month of pregnancy(18-20 weeks), USG may be repeated in between the trial, if necessary depending on patient’s condition. All the outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.