| CTRI Number |
CTRI/2023/07/054944 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Garbhini Chardi (Emesis Gravidarum) thrrough ayurveda. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Eladi choorna in the management of garbhini chardi w.s.r 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 Suniti Tanwar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic college and Hospital Kurukshetra. |
| Address |
Room.NO 110, Department of Prasuti Tantra Evam Stree Roga. Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suniti Tanwar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic college and Hospital Kurukshetra. |
| Address |
Room.NO 110, Department of Prasuti Tantra Evam Stree Roga. Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suniti Tanwar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic college and Hospital Kurukshetra. |
| Address |
Room.NO 110, Department of Prasuti Tantra Evam Stree Roga. Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic college and hospital Kurukshetra. |
|
|
Primary Sponsor
|
| Name |
Dr Sahil |
| Address |
OPD.No 15, Prasuti Tantra Evam Stree Roga, Shri Krishna Government Ayurvedic College and Hospital Kurukshetra Haryana. Pin-136118 |
| 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 Sahil |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra. |
OPD no. 15, Department of Prasuti Tantra Evam Stree Roga. Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA |
9518041125
sahilpaul77185@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O210||Mild hyperemesis gravidarum. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Doxinate Plus | Dose-10mg Route -Oral
Frequency-BID (Before meal) Duration-30 days
Dosage Form-Tablet
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eladi chooran, Reference: Bhaisjya Ratnavali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu and sita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Subjects having confirm diagnosis of pregnancy.
2 Subjects presenting the classical symptoms of Garbhini chardi.
3 Subjects presenting with symptoms of Emesis Gravidarum.
4 Patients of age group between 20 to 40 years.
5 All patient diagnosed with chardi during pregnancy (both primi and muitigravida)
|
|
| ExclusionCriteria |
| Details |
1 Subjects with Hyperemesis Gravidarum.
2 vomiting caused due to ectopic pregnancy and vesicular mole.
3 Vomiting caused due to any medical and surgical condition.
4 Vomiting caused due to Red degeneration fibroid, Twisted Ovarian Tumor
5 Patient with PIH (pregnancy induced hypertension), GDM (gestational diabetes mellitus) and High-risk pregnancies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Eladi Choorna in management of Garbhini Chardi w.s.r. Emesis Gravidarum.
2.Improvement in subjective and objective criteria of patient. |
Duration of Treatment -It will be given for 60 days
Follow up: It will be done on 8th, 15th and 30th Day during treatment and reassessment will be done after every 15 days for 1 month . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the garbhini chardi in diffrent ayurvedic text & correlate it with Emesis Gravidarum.
2. To find out an ayurvedic approach for the management of Garbhini Chardi. |
Duration of Treatment -It will be given for 60 days
Follow up: It will be done on 8th, 15th & 30th Day during treatment & reassessment will be done after every 15 days for 1 month. |
|
|
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)
|
20/07/2023 |
| 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
|
Health of a pregnant women is at most important. A series of physiological and psychological changes occurs in different stages of pregnancy. Some of them may ends up in discomfort and trouble. Ayurveda classics have mention Garbhini chardi as vyakta garbha lakshana which can be correlated with Emesis gravidarum.In our classic various simple, safe formulation and recipes have been mentioned which can be easily incorporative in day-to-day life by a pregnant women.Ayurveda is the science which emphasized both preventive and curative aspects of disease so it is a basics duty of every obstetrician to give healthy child to a healthy mother. Garbhini avastha is most delicate state so in this condition treatment should be very gentle and assuring. Shamana chikitsa is preferred instead of shodana chikitsa. The study is important in view of enhancing scope of ayurvedic treatment of pregnant women suffering from chardi.
In our classic various simple, safe formulation and recipes have been mentioned which can be easily incorporative in day-to-day life by a pregnant women.They are easy to prepare and easily available.There are end numbers of Yoga (formulations) explain in the context of Chardi which are gentle,potent and easily palatable.Eladi choorna will be selected here as a trial in the management of Garbhini chardi as this yoga has the quality has property like easily Palatable ,Hridaya ,Deepana ,Pachana ,Rochana ,Grahi and Chardighana. |