| CTRI Number |
CTRI/2024/09/073287 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Bhunimba Kalka and Kustumbari Kalka on the management of Garbhini Chardi with special reference to Emesis Gravidarum |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHUNIMBA KALKA AND KUSTUMBARI KALKA ON THE MANAGEMENT OF GARBHINI CHARDI w.s.r TO EMESIS GRAVIDARUM
|
| 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 Sonu Raghuwanshi |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room
number 1 Mansarovar Ayurvedic Medical College Hospital and
Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7000103961 |
| Fax |
|
| Email |
sonuraghuwanshi2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Ray |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room
number 1 Mansarovar Ayurvedic Medical College Hospital and
Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8319356714 |
| Fax |
|
| Email |
sucheta.ray1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucheta Ray |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room
number 1 Mansarovar Ayurvedic Medical College Hospital and
Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8319356714 |
| Fax |
|
| Email |
sucheta.ray1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra avum Stri Roga , 3rd Floor , Room no 1
Mansarovar Ayurvedic Medical College Hospital and Research Centre
Hinotiya Alam , Kolar Road Bhopal (M.P.)
Pin code : 462042
INDIA |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room
number 1 Mansarovar Ayurvedic Medical College Hospital and
Research Centre Hinotiya alam Kolar road Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sonu Raghuwanshi |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Department of Prasuti
tantra evum Stri roga
third floor room number
1 Hinotiya alam Kolar
road Bhopal
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7000103961
sonuraghuwanshi2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mansarovar Ayurvedic College hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O219||Vomiting of pregnancy, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kustumbari Kalka, Reference: Yogratnakar, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: Kustumbari Kalka, 6gm dose BID,After Food | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhunimba Kalka, Reference: Haritasamhita, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: Bhunimba Kalka, 6gm dose BID , After Food |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman having the sign and symptoms of Garbhini Chardi as described in Ayurvedic classics as well as modern medical science will be selected |
|
| ExclusionCriteria |
| Details |
Patients having Hyperemesis Gravidarum.
Patients having Vomiting caused due to other systemic disorders ulcer, liver disorder, renal calculi, gall bladder stone, appendicitis etc.
Patients have Vesicular mole.
Patients having Chardi in second & third trimester.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of Vomiting, Salivation, Nausea, Low Appetite symptom during first trimester in Pregnancy |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
UPT /Serum HCG
CBC
ESR
RBS |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/09/2024 |
| 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
|
Nausea and Vomiting during pregnancy is a worldwide common obstetrical problem seen in the first trimester in about 70-80%-of pregnant women. It leads to dehydration, nutritional and metabolic imbalances causing physical and psychological disturbance which in turn affects the health of the fetus. So it is mandatory to initiate the remedies and care at an early phase to prevent and manage these health problems and their complication .The present study drug “BHUNIMBA KALKA AND KUSTUMBARI KALKA†is used for the management of Garbhini Chardi.The aim of this study is to establish an cost effective , harmless Ayurvedic medication for the treatment of Garbhini Chardi
|