| CTRI Number |
CTRI/2023/06/054053 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of the efficacy of powdered egg for the growth of fetus in pregnancy |
|
Scientific Title of Study
|
A Study Of The Efficacy Of Powdered Aamgarbha Basti In Upavishtaka- Intrauterine Growth Restriction |
| 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 Jeel Dadhania |
| Designation |
MS (PTSR) Scholar |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemed to be University) |
| Address |
Department of Prasuti Evam Stri roga, Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Pune- Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7016938621 |
| Fax |
|
| Email |
jdadhania.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati S Mohite |
| Designation |
Prof. and HOD, Department of Prasuti Evam Stri Roga |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemed to be University) |
| Address |
Department of Prasuti Evam Stri Roga, Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Pune-Satara Road,Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822004562 |
| Fax |
|
| Email |
swati.mohite@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati S Mohite |
| Designation |
Prof. annd HOD, Department of Prasuti Evam Stri Roga |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemed to be University) |
| Address |
Department of Prasuti Evam Stri Roga, Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Pune-Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822004562 |
| Fax |
|
| Email |
swati.mohite@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati ayurved hospital and college, Bharati Vidyapeeth (Deemed to be University), Pune-Satara road, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Dr Jeel L Dadhania |
| Address |
Department of Prasuti Evam Stri Roga, Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Pune-Satara road, Pune-43 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Jeel L Dadhania |
Bharati ayurved hospital, BVDU, pune |
Department of Prasuti Evam Stri Roga, First floor, Bharati ayurved hospital, BVDU, Pune-43
Pune
MAHARASHTRA |
7016938621
jdadhania.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O359||Maternal care for (suspected) fetal abnormality and damage, unspecified. Ayurveda Condition: UPAVISHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | amagarbha basti | (Procedure Reference: Charak samhita, Sharirsthana, 8/27, Procedure details: 1. 125gms whole egg powder will be taken.
2. 150ml water will be added and homogenous mixture will be formed.
3. Whole mixture will be filled in 150ml plastic syringe and feeding tube no. 7 will be attached.
4. Pateint will be made to lie down in left lateral position with left leg straight and right leg slightly bent.
5. Basti will be introduced per rectum and patient will be asked to relax for 15-20 minutes.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
PREGNANT WOMEN OF 18-35 YEARS OF AGE, CLINICALLY AND SONOGRAPHICALLY DIAGNOSED AS IUGR.
PERIOD OF GESTATION- 24-37 WEEKS.
PREGNANT WOMEN HAVING PIH.
ALL PREGNANT WOMEN WITH ANY BMI. |
|
| ExclusionCriteria |
| Details |
PREGNANT WOMEN HAVING EGG ALLERGY.
SEVERE OLIGOHYDRAMNIOS WITH SEVERE IUGR. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foetal weight gain as per Shepherds chart |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nourishment of mother & foetus |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2023 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission of Institutional Ethics Committee will be taken. • Registration at CTRI will be done. • Standardized whole egg powder will be acquired from the market. • Pregnant women visiting the Department of Prasuti Tantra Evam Stri Roga at Bharati
Ayurved Hospital will be screened clinically and sonographically for IUGR and after
taking informed consent women will be enrolled in the study. CRF will be filled after
enrollment. • Once the patient is enrolled, all the parameters will be examined and aamgarbha basti
will be given twice a week. The follow ups and USG will be done every 15 days till
desired effect i.e. weight gain of the foetus. • Pregnant women will be discontinued or dropped off from the research study if- 1. She misses two consecutive doses of aamgarbha basti. 2. She rejects medication. 3. She develops protein allergy symptoms. 4. She develops diarrhoea. |