| CTRI Number |
CTRI/2024/05/067224 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study The Effect of Bhunimba Churna With Madhu In Garbhini Hrullas (Nausea In Pregnancy) |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Bhunimba Churna With Madhu In Garbhini Hrullas; Nausea In Pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSmruti Vijaykumar Honmute |
| Designation |
MS Scholar |
| Affiliation |
DR. D.Y. Patil College Of Ayurveda and Research Centre |
| Address |
OPD no 2 Stree Rog and Prasuti Tantra department , DR. D. Y. Patil college of ayurveda and research centre ,Sant Tukaram Nagar, Pimpari, Pune , Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9403761231 |
| Fax |
|
| Email |
smrutihonmute99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rahul Barathe |
| Designation |
Assistant Professor Stree Rog and Prasuti Tantra |
| Affiliation |
DR. D.Y. Patil College Of Ayurveda and Research Centre |
| Address |
OPD no 2 Stree Rog and Prasuti Tantra department , DR. D. Y. Patil college of ayurveda and research centre ,Sant Tukaram Nagar, Pimpari, Pune , Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8484048002 |
| Fax |
|
| Email |
rahul.barathe@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSmruti Vijaykumar Honmute |
| Designation |
MS Scholar |
| Affiliation |
DR. D.Y. Patil College Of Ayurveda and Research Centre |
| Address |
OPD no 2 Stree Rog and Prasuti Tantra department , DR. D. Y. Patil college of ayurveda and research centre ,Sant Tukaram Nagar, Pimpari, Pune , Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9403761231 |
| Fax |
|
| Email |
smrutihonmute99@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. D.Y. Patil College Of Ayurveda And Research Centre , Sant Tukaram Nagar , Pimpari,Pune,Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
DR Smruti Vijaykumar Honmute |
| Address |
DR. D.Y.Patil college of ayurveda and research centre ,Sant Tukaram Nagar Pimpari, Pune , Maharashtra 411018 |
| 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 |
| Dr Smruti Honmute |
DR D. Y. PATIL College Of Ayurveda And Research Centre , Pimpari,Pune |
OPD NO 2 and IPD of Stree Rog and Prasuti Tantra Department, DR. D.Y. Patil College of Ayurveda and Research Centre Sant Tukaram Nagar, Pimpari , Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9403761231
smrutihonmute99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhunimba Churna with Madhu, Reference: Harit Samhita Garbhopdrava Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Drug will be given 6 gm BID with equal amount of madhu. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Both primigravida and multigravida
1st and 2nd trimester |
|
| ExclusionCriteria |
| Details |
Molar pregnancy
Pregnancy with severe vomiting
Appendicitis
Hepatitis
Pancreatitis presenting with vomiting
Pregnancy with severe dehydration
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Bhunimba Churna with Madhu in Garbhini Hrullas |
14 days study with follow up on 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Bhunima Churna with Madhu in Garbhini Hrullas |
14 days study with follow up on 7th and 14th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="6"
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
|
THIS IS SINGLE ARM CLINICAL STUDY . THE AIM OF THE STUDY IS" TO EVALUATE THE EFFICACY OF BHUNIMBA CHURNA WITH MADHU IN GARBHINI HRULLAS (NAUSEA IN PREGNANCY)" TOTAL 40 PATIENTS WILL BE ENROLLED AND 6 GRAMS BHUNIMBA CHURNA WILL BE GIVEN WITH EQUAL AMOUNT OF MADHU TWICE A DAY BEFORE MEAL. THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE BETWEEN 21YEAR TO 40 YEAR . AYURVEDIC FORMULATION WILL BE GIVEN ON 0TH ,7TH,14TH DAY AND TOTAL DURATION OF STUDY WILL BE 14 DAYS. SUBJECTIVE AND OBJECTIVE CRITERIA WIIL BE STUDIED .
|