| CTRI Number |
CTRI/2025/10/095981 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Somaghrita in Pregnant Females with special reference to baby weight. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the efficacy of Somaghrita in Garbhini Paricharya with special reference to Baby Weight. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeny Mukesh Bhatt |
| Designation |
Assistant Professor, PhD (Sch) |
| Affiliation |
DR. G.D.POL FOUNDATION, Y.M.T. Ayurvedic Medical College & Hospital, Kharghar |
| Address |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College, 3rd floor, PTSR department, Sector no- 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeny Mukesh Bhatt |
| Designation |
Assistant Professor, PhD (Sch) |
| Affiliation |
DR. G.D.POL FOUNDATION, Y.M.T. Ayurvedic Medical College & Hospital, Kharghar |
| Address |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College, 3rd floor, PTSR department, Sector no- 4, Kharghar, Navi Mumbai - 410210
MAHARASHTRA
410210
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeny Mukesh Bhatt |
| Designation |
Assistant Professor, PhD (Sch) |
| Affiliation |
DR. G.D.POL FOUNDATION, Y.M.T. Ayurvedic Medical College & Hospital, Kharghar |
| Address |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College, 3rd floor, PTSR department, Sector no- 4, Kharghar, Navi Mumbai - 410210
MAHARASHTRA
410210
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College, 3rd floor, PTSR department, Sector no- 4, Kharghar, Navi Mumbai - 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Jeny Mukesh Bhatt |
| Address |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College & Hospital, Sector-4, Kharghar |
| Type of Sponsor |
Private medical college |
|
|
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 Jeny Mukesh Bhatt |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College & Hospital |
Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College, 3rd floor, PTSR department, Sector no- 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA |
9167541086
dr.jenybhatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. G.D. Pol Foundation, Y.M.T. Ayurvedic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
In Pregnant Females-Rather than mere supplementation of Iron,Calcium nourishing the pregnant lady with something more which takes care of all round development of the fetus including weight gain. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Iron & Calcium Tablets | Orally Iron tablets and Orally Calcium tablets in BD dose will be given. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Somaghrita, Reference: Bhaishajya Ratnavali Bhag 3/85-91, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant lady in age group 18-35 yrs irrespective of parity |
|
| ExclusionCriteria |
| Details |
1) Bad obstetric History (Previous abortion or miscarriage)
2) H/O and diagnosed PIH, Anemia (less than 8 gm%), Jaundice, DM, T.B., Heart disease
3) Obesity, Renal disease, chronic HTN, worm infestations, Asthama, Thyroid dysfunction
4) Pregnant with acute pain abd.
5) Obstetrical shock, Acute renal failure
6) Or any other systemic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
WHO reports shows that the median for baby birth weight in male and female baby is 3.3kg & 3.2 kg respectively. This median can be increased if Ayurvedic Medicine like Somaghrita is taken in pregnancy by the mother. So, such medicine can be a boon to the society.
|
at baseline , at 20 weeks , at 28 weeks & at birth of baby (around 36 to 40 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Pregnant Females - 1.Rather than mere supplementation of Iron
and Calcium nourishing the pregnant lady with something more which takes care
of the all round development of the fetus including weight gain. 2. WHO reports shows that the median for
baby birth weight in male and female baby is 3.3kg & 3.2 kg respectively.
This median can be increased if Ayurvedic Medicine like Somaghrita is
taken in pregnancy by the mother. So, such medicine can be a boon to the
society.
3. Somaghrita, has rasayana dravyas in it which have qualities of Bruhan, Balya, Jivaniya, Oja
Vardhan, etc which eventually leads to increase in baby birth weight. •GROUP
1(Trial)-10 Patients were given Somaghrita
20 ml twice a day after food from 2nd
month of pregnancy for 6 months with regular ANC care on Iron and Calcium. •GROUP
2(Control)-10 Patients were observed from 2nd
month of pregnancy for 6 months with regular ANC care on Iron and Calcium. Assessment Criteria - Baby Weight will be measured as per USG at
5th
month, 7th
month and finally at birth of baby i.e. baby birth weight. |