| CTRI Number |
CTRI/2024/10/075424 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of vomiting in pregnancy |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Bilva Majja and Bhunimba in Garbhini Chhardi w.s.r. to Emesis Gravidarum |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Yadav |
| Designation |
M.S Scholar Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rishikul Campus Uttarakhand Ayurved University Haridwar |
| Address |
P.G Department of Prasuti Tantra Evum Stree Roga
OPD No 9
Rishikul Campus
Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9350594187 |
| Fax |
|
| Email |
drmoniyadav4444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hem Prakash |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Campus Uttarakhand Ayurved University Haridwar |
| Address |
PG Department of Prasuti Tantra Evum Stree Roga
Rishikul Campus
Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456346224 |
| Fax |
|
| Email |
hemprakash78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Yadav |
| Designation |
M.S Scholar Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rishikul Campus Uttarakhand Ayurved University Haridwar |
| Address |
P.G Department of Prasuti Tantra Evum Stree Roga
OPD No 9
Rishikul Campus
Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9350594187 |
| Fax |
|
| Email |
drmoniyadav4444@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Prasuti Tantra Evum Stree Roga
OPD No 9
Rishikul Campus Haridwar
249401
Uttarakhand Ayurved University Haridwar
Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Haridwar Uttarakhand Ayurveda University |
| Address |
P.G Department of Prasuti Tantra Evum Stree Roga
OPD No 9
Rishikul Campus
Uttarakhand Ayurved University Haridwar 249401
Uttarakhand India
Rishikul Campus
Uttarakhand Ayurved University Haridwar
Uttarakhand India
|
| 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 Monika Yadav |
Rishikul Campus Haridwar |
P.G Department of Prasuti Tantra Evum Stree Roga
OPD No 9
Rishikul Campus
Uttarakhand Ayurved University Haridwar 249401
Uttarakhand India
Hardwar
UTTARANCHAL |
09350594187
drmoniyadav4444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilva majja , Reference: Yogratnakar, Stree Roga Chikitsa, Page no 421, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Lajambu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhunimba , Reference: Harita Samhita, Tritiya Sthan, 51/6, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sharkara), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Married pregnant women of age between 20 to 35 years
2. All patients diagnosed with Garbhini Chhardi in first trimester of pregnancy irrespective of parity and religion |
|
| ExclusionCriteria |
| Details |
1. Patients in whom vomiting is seen in second and third trimester of pregnancy
2. Patients with hyperemesis gravidarum or weight loss more than 4.5 kg
3. Patients with twins pregnancy, ectopic pregnancy, vesicular mole
4. Pregnant women with Diabetes mellitus, HIV, Hepatitis B, Hepatitis C, Hypertension, Uraemia, Jaundice
5. Vomiting caused due to other systemic disorders like known case of Peptic ulcer, Appendicitis, Intestinal obstruction, Cholecystitis, Urinary tract infections, Intestinal infestation
6. Patient in whom vomitus is coffee brown colour or mixed with blood |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in following parameters.
1. Nausea
2. Frequency of vomiting
3. Aruchi(Anorexia)
4. Daurbalya(Generalised weakness)
5. Shrama (Fatigue)
6. Vibandha(constipation)
7. Shira shoola(Headache) |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in following parameters-
1. weight loss
2. Quantity of vomitus
3. Content of vomitus |
1.5 month |
|
|
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)
|
05/11/2024 |
| 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 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
|
Ayurvedic classics have mentioned Garbhini Chhardi as one among the Vyakta Lakshan, which can be correlated with disease Emesis Gravidarum or Vomiting in pregnancy. in our classics literature they have mentioned excessive salivation, nausea, vomiting as common indicators of normal pregnancy. Emesis gravidarum are the common complaints during the first half of pregnancy. Garbhini Avastha is termed as delicate state. Aacharya Charaka has compared pregnant women with Taila Poorna Patra which can spill off by small disturbances hence seeking proper attention. So, the treatment should be very gentle and assuring. There is need for an alternative safe and patent remedy. While treating pregnant lady the medication is very gentle, potent, easily palatable and also they can be used for long term treatment without any harm to the foetus. |