| CTRI Number |
CTRI/2024/12/078471 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study effect of Bala Ahvagandhadi Ksheerpak on Garbhashosh IUGR |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Bala Ahvagandhadi Ksheerpak in manegement of Garbhashosh (Intra Uterine Growth Restriction -IUGR) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSonal Nitave |
| Designation |
PG Scholer |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya, Solapur |
| Address |
OPD no 4 Prasutitantra evum streerog department , Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukruvar peth, near juni faujdar chowki , Solapur
Maharashtra
413002
India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9423270958 |
| Fax |
|
| Email |
sonalnitave301999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVeena Jawale |
| Designation |
HOD, Prasutitantra evum streerog department |
| Affiliation |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
| Address |
OPD no 4 Prasutitantra evum streerog department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya118/119
shukrawar peth near juni faujdar chawdi, solapur, MAHARASHTRA
413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9028244410 |
| Fax |
|
| Email |
veena.jawale@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSonal Nitave |
| Designation |
PG Scholer |
| Affiliation |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
| Address |
OPD no 4 Prasutitantra evum streerog department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth nearjuni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9423270958 |
| Fax |
|
| Email |
sonalnitave301999@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 4 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119
shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA
413002
India |
|
|
Primary Sponsor
|
| Name |
Dr.Sonal Nitave |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119
shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA
413002 India |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| DrSonal Nitave |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
OPD no 4 Prasutitantra evum streerog department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA |
9423270958
sonalnitave301999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya Solapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O251||Malnutrition in pregnancy. Ayurveda Condition: GARBA-VYAPAT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bala Ahvagandhadi Ksheerpak , Reference: Charak samhita sharirstan 8 -27, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women with IUGR having Gestational age between 28-36 weeks (Calculated from 1st USG) |
|
| ExclusionCriteria |
| Details |
Subject having chronic hypertension
Subject having STD
Subject having DM
Multiple pregnancies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate the efficacy of Bala Ahvagandhadi Ksheerpak in manegement of Garbhashosh (Intra Uterine Growth Restriction -IUGR) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate the efficacy of Bala Ahvagandhadi Ksheerpak in manegement of Garbhashosh Intra Uterine Growth Restriction -IUGR |
30 days after diagnosis of Garbhashosh |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Intra uterine growth restriction is one of the importance symptom observed in day to day practice. Fetal growth restriction is the second leading cause of perinatal morbidity and mortality followed only by prematurity. The incidence of IUGR is estimated to be approximately 10-15% in a general of obstetrics population. IUGR is defined as babies with birth weight below the 10th percentile for given the gestational is for a given population as a result of pathological restriction in their ability to grow. According to modern science there is no effective intervention to improve FGR accept delivery. In Ayurved , IUGR is considered as Garbhashosh . Garbhashosh is also stated as Vatabhipanna Garbha , it can be defined as under development or under nourishment of part of whole body of the foetus in utero. Our ultimate goal is "Healthy at the mother’s stronger and healthy will be the child "his is an attempt to expand the concept of igr according to Ayurveda and to yield a flourishing result to this world by wide problem through Ayurveda this topic has be selected for study. The study has be conducted for 30 days after diagnosis of Garbhashosh . There will be follow up on each 7th day after diagnosis of Garbhashosh
|