| CTRI Number |
CTRI/2025/02/081109 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of Ayorajovyoshyadvleha and Vibhitakadi Vatak in participants of garbhini pandu w.s.r to Gestational Anaemia |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIBHITAKADI VATAK AND AYORAJOVYOSHYADVLEHA IN MANAGEMENT OF GARBHINI PANDU W.S.R TO GESTATIONAL ANAEMIA. |
| 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 karnika |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Street Roga
Government Ayurvedic College And Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9097210669 |
| Fax |
|
| Email |
nandankarnikanandan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Kumari |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Street Roga
Government Ayurvedic College And Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr karnika |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Evum Stree Roga
Government Ayurvedic College And Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9097210669 |
| Fax |
|
| Email |
nandankarnikanandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College And Hospital Kadamkuan |
|
|
Primary Sponsor
|
| Name |
Ayurveda College Health Department Government Of Bihar |
| Address |
Government Ayurvedic College And Hospital Kadamkuan patna Bihar 800003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabha Kumari |
Government Ayurvedic College And Hospital |
Government Ayurvedic College And Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR |
7004860634
dr.prabhapandey@yahoo.in |
| Dr Prabha Kumari |
Government Ayurvedic College And Hospital |
Department Of Prasuti Tantra Evum Stree Roga Room no.1
Patna
BIHAR |
7004860634
dr.prabhapandey@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P90-P96||Other disorders originating in the perinatal period. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vibhitakadi Vatak , Reference: Sushruta Samhita By Kaviraj Ambikadutt Shastri Chaukhamba Sanskrit sansthan part 2, Edition reprint 2018 Uttartantra adhyay 44, pandurogpratishedam , page no- 373,374, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vibhitakadi Vatak Sushruta Samhita By Kaviraj Ambikadutt Shastri Chaukhamba Sanskrit sansthan part 2, Edition reprint 2018 Uttartantra adhyay 44, pandurogpratishedam , page no- 373,374, Reference: Sushruta Samhita By Kaviraj Ambikadutt Shastri Chaukhamba Sanskrit sansthan part 2, Edition reprint 2018 Uttartantra adhyay 44, pandurogpratishedam , page no- 373,374, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of (12-40 weeks)
Patients having hb% equal to or less than 10 gm% but more than 8 gm%
Patients with clinical signs and symptoms of Pandu (anaemia) |
|
| ExclusionCriteria |
| Details |
Women who have had four or more pregnancies and deliveries
Pre-eclampsia and eclampsia
Complicated pregnancies...antepartum haemorrhage,
Pregnancy associated with medical conditions...e.g,
Cardiovascular disease
Kidney disease
Diabetes
Tuberculosis
Hepatitis (liver disease)
Patients having hb% count less than 8gm% and more than 10gm% |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of the intervention |
8weeks (about 2 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of the intervention with respect to other |
8weeks(about2months) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
These combinations help in the improvement of metabolism of pregnant women. This Ayurvedic drug has ingredients which are Non-invasive, easily available and cost effective. It will also improve the appetite of the pregnant women that is why "A Clinical Study To Evaluate The Efficacy Of Vibhitakadi Vatak And Ayorajovyoshyadvleha In Management Of Garbhini Pandu W.S.R To Gestational Anaemia" has been chosen by me |