| CTRI Number |
CTRI/2024/10/075630 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlative study of weight gain during 3rd and 4th month of pregnancy |
|
Scientific Title of Study
|
Comprehensive study of Anatomico-Physiological
changes occuring during fourth month of pregnancy in
Garbhini w.s.r. to Garbhini Gurugatratva |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranapariya Radhika Dineshbhai |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital-Lucknow |
| Address |
P.G. Department of Rachana Sharir,
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow(U.P.)
P.G. Department of Rachana Sharir,
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow(U.P.)
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7283909091 |
| Fax |
|
| Email |
radhikaranapariya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Nidhi |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital-Lucknow |
| Address |
P.G. Department of Rachana Sharir,
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow(U.P.)
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9454598439 |
| Fax |
|
| Email |
divyanidhi28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Nidhi |
| Designation |
Assistant Professor |
| Affiliation |
State Ayurvedic College and Hospital-Lucknow |
| Address |
P.G. Department of Rachana Sharir,
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow(U.P.)
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9454598439 |
| Fax |
|
| Email |
divyanidhi28@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital-Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow,
Uttar Pradesh (226004) |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital-Lucknow |
| Address |
State Ayurvedic College and Hospital-Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow,
Uttar Pradesh (226004) |
| Type of Sponsor |
Government 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 Ranapariya Radhika Dineshbhai |
State Ayurvedic College and Hospital Lucknow |
OPD No.10, P.G. Department of Striroga & Prasuti Tantra
Lucknow
UTTAR PRADESH |
7283909091
radhikaranapariya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individual without any illness or systemic disease |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:This is an observational study. Here I only observed the anatomical and physiological changes related to weight gain during forth month of pregnancy., Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:This is an observational study. Here I only observed the anatomical and physiological changes related to weight gain during forth month of pregnancy. , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. 50 cases will be taken between the age group of
25 years to 35 years.
2. Cases will be followed from the OPD coming
under the ante-natal care.
3. Healthy Garbhini.
4. Pregnant women preferably primigravida will be
included in study. |
|
| ExclusionCriteria |
| Details |
1. Cases will not be taken below the age group of
25 years and above the age of 35 years.
2. Cases having congenital anomalies, genetic
disorders, prehistory of any chronic diseases
such as hypertension, diabetes, thyroid,
tuberculosis, any kind of infection or
inflammation.
3. Subjects not willing to participation in the
study will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is a positive weight gain during the fourth month of pregnancy. |
The data will be collected at 12th week and 16th week of pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no positive weight gain during the fourth month of pregnancy. |
The data will be collected once |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
Modification(s)
|
50 primigravidae will be selected as per case proforma. Individuals will be observed and questioned as a part of history taking. Accordance with the proforma, an anatomical and physiological changes related to Garbhini Gurugatrata will be analyzed to validate the Ayurvedic perspective of Masanumashika Garbha Vridhi. Acharya Charak mentioned specific changes during the second trimester of pregnancy in masanumasik garbha vriddhi. He quoted that garbhini experienced Gurugatratva during 4th month and Chakrapani commented that this Gurugatratva is due to garbh sthiratva compared to third month of pregnancy. So, this study enlight the ayurvedic perspective of pregnancy with the help of modern science which is beneficial for the future ayurvedic research scholars and students. |