| CTRI Number |
CTRI/2017/02/007969 [Registered on: 27/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EARLY PREGNANCY CARE |
|
Scientific Title of Study
|
Management of First trimester Pregnancy with Rasayana and Nasya and Micronized progesterone A Randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Resmi V Rajagopal |
| Designation |
MS Second year |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Room no 319 PG Ladies Hostel Department of StreeRoga and Prasooti Tantr IPGT and RA JAMNAGAR Gujarat Ayurved University
Room No 319 PG Ladies Hostel Department of Streeroga and Prasooti Tantr IPGT and RA Jamnagar Gujarat Ayurved University Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9400879287 |
| Fax |
|
| Email |
resmirajagopal999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Laxmipriya Dei |
| Designation |
Professor and HOD |
| Affiliation |
IPGT AND RA Jamnagar |
| Address |
Department of Streerog and Prasootitantra IPGT and RA Gujarat Ayurved University Jamnagar
Department of Streerog and Prasootitantra IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa B Donga |
| Designation |
Associate Professor |
| Affiliation |
IPGT and RA Jamnagar |
| Address |
Dept of Streerog and Prasootitantra IPGT and RA Gujarat Ayurved University Jamnagar
Depart of Streerog and Prasootitantra IPGT and RA Gujarat Ayurved University JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GAU JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF POST GRADUATE TEACHING AND RESEARCH IN AYURVED GUJARAT AYURVED UNIVERSITY JAMNAGAR |
| Address |
INSTITUTE OF POST GRADUATE TEAHING AND RESEARCH IN AYURVEDA JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Resmi V Rajagopal |
PG Hospital |
PG Hospital Streerog and Prasootitantra Department
IPGT and RA Jamnagar
GAU Jamnagar
Jamnagar
GUJARAT |
9400879287
resmirajagopal999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee IPGT and RA GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women in first trimester of pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A Rasayana granules anubhoot yoga in opd of IPGT & RA
and Vatashrunga nasya susruta samhita sareerastan 2 32 |
Rasayan granules contains guduchi Tinospora cordifolia Amalaki Embelica officinalis Jeevanti Leptadenia reticulata Shatavari Asperagus racemosus Bala Sida cordifolia Draksha Vitis vinifera Arjuna Terminalia arjuna and sita sugar 10 gm bd orally with milk brfore food till the first trimester got completed with min duration of 42 days
8vatashrunga triturated with milk and instilled in either right or left nostrils 4 drops continued for first 7 days starting with rasayan granules |
| Intervention |
group B Rasayan granules anubhoot yoga in opd IPGT and RA |
Rasayan granules contains guduchi Tinospora cordifolia Amalaki Embelica officinalis Jeevanti Leptadenia reticulata Shatavari Asperagus racemosus Bala Sida cordifolia Draksha Vitis vinifera Arjuna Terminalia arjuna and sita sugar 10 gm bd orally with milk before food untill the first trimester got completed with a minimum duration of 42 days |
| Comparator Agent |
micronized progesterone 200mg tablet |
micronized progesterone 200mg one tablet morning and night orally with water after food for 42 days minimum or untill the 12 weeks of gestation completed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
pregnant ladies just after UPT test positive starting from 6 weeks upto 12 completed weeks and also the same above with any of the following conditions bad obstetric hstory elderly primi delayed foetal pole development choriodecidual hemorrhage |
|
| ExclusionCriteria |
| Details |
women below 18 years and above 35 years
pregnancy with systemic cardiac hematological neurological autoimmune endocrinal renal hepatic thyroid disorders Diabetes Mellitus Reproductive tract Ca Pelvic Inflammatory Disorders Sex Transmitting Disorders TORCH and VDRL positive |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
continue the first trimester of pregnancy without any risk
improve the maternal and foetal wellbeing |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the effect of Rasayana granules vatashrunga nasya and micronised progesterone in continuing the pregnancy and minimising complications and discomforts in first trimester |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
During 1st trimester of pregnancy fetus is craving for food as mother is unable to intake due to nausea and vomiting So there may be a chance of nutritional deficiency to the fetus ultimately results in miscarriages During the embryonic stage before formation of solid dhatu fetus gets the nutrition through osmosis and from peripheral capillaries In Ayurveda Rasayana therapy defined as a rejuvenating agent for promotion of health and cure of the diseases in all stages of life According to Harita Rasayana promotes strength to the body and Indriyas Here use of Rasayana act as a supportive for pregnancy fetal development and proper organogenesis during embryonic stageThe best time for administration of Rasayana Purve Vayasi Madhye va Here 1st trimester has been considered as purvevaya Here Nasya is to be used for effective Garbhasthapaka Aushadha instilled through nostril directly stimulate the Sringataka marma for balancing of all the Indriyas, Srotas and doshas Some specially mentioned drugs when administered properly acts as effective Garbhasthapaka in conjugation with upgrading the qualities of fetus In Sushruta Samhita Dalhana Acharya has mentioned above Nasya for Garbha Grahanaaya Garbha Sthapanaartham and Putra Apathya Jananaartham Vagbhatacharya in Ashtanga Sangraha quoted the same Group A Rasayan granules 10 gm bd in empty stomach after urine pregnancy test positive continuing for 6 weeks throughout the first trimester and 8 vatashrunga triturated with milk nasal instillation either right or left 3 or 4 drops for 3 cocecutive days after urine pregnancy test positive Group B Rasayan granules 10 gm bd in empty stomach after urine pregnancy test positive continuing for 6 weeks throughout the first trimester Group C micronised progesterone tab 200 mg bd for 6 weeks after urine pregnancy test positive throughout the first trimester |