CTRI

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CTRI Number

CTRI/2021/11/037738 [Registered on: 01/11/2021] Trial Registered Prospectively

Last Modified On:

01/11/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To study effect of bhunimba kalk in Garbhini Chardi (vomiting due to pregnancy)

Scientific Title of Study

Open randomized clinical control trial of Bhunimba kalk in Garbhini Chardi(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	Sandhyarani Rajebhau Akate
Designation	PG Scholar Prasutitantra Evum Strirog
Affiliation	Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate and Research Centre, Ashta
Address	Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Pin code 416 301 Sangli MAHARASHTRA 416301 India
Phone	9673592218
Fax
Email	sandhyaraniakate910@gmail.com

Details of Contact Person
Scientific Query

Name	Vd Dilip Vitthal Katare
Designation	Proffesor
Affiliation	Hon.shri.Annasaheb Dange Ayurved Medical College Ashta Tal- Walwa Dist- Sangali
Address	Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Pin code 416 301 Sangli MAHARASHTRA 416301 India
Phone	9881215521
Fax
Email	drdilipkatareashta@gmail.com

Details of Contact Person
Public Query

Name	Sandhyarani Rajebhau Akate
Designation	PG Scholar Prasutitantra Evum Strirog
Affiliation	Hon.Shri. Annasaheb Dange Ayurved Medical College Ashta,Tal- Walwa Dist- Sangli
Address	Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Hon.Shri. Annasaheb Dange Ayurved Medical College and PG research center Ashta,Tal- Walwa Dist- Sangli Pin code 416301 Sangli MAHARASHTRA 416301 India
Phone	9673592218
Fax
Email	sandhyaraniakate910@gmail.com

Source of Monetary or Material Support

Hon.shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta

Primary Sponsor

Name	Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta
Address	Ashta Tal- Walwa Dist- Sangli Pin - 416301
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Sandhyarani Rajebhau Akate	Dhanwantari Hospital Ashta	Striroga and Prasuti tantra OPD Hon. Annasaheb Dange Ayurved Medical college and PG research center Ashta Tal- Walwa Dist- Sangli Pin- 416301 Sangli MAHARASHTRA	9673592218 sandhyaraniakate910@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O210\|\|Mild hyperemesis gravidarum. Ayurveda Condition: Garbhini Chardi,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Bhunimb kalka, Reference: Harit trutiya sthan 51/6, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information:
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Dhatri Toyam, Reference: Bhavprakash Madhyamkhand 17/20, Route: Oral, Dosage Form: Phanta, Dose: 20(ml), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information:

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	Patient age group between 18-35 yrs. Patients presenting with pratyatm lakshana of garbhini chardi. Patient diagnosed having emesis gravidarum

ExclusionCriteria

Details

Patients with PIH, anaemia in pregnancy APH, diseases related to
Uro-genital system.
Patients with systemic disorder like diabitis melitus , hypertension,
tuberculosis ,HIV.
Lactating Mother.
Patients on Hormonal Therapy, OC pills.
Patient with hyperacidity.

Method of Generating Random Sequence

Other

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Bhunimba Kalk is effective in Garbhini Chardi	7 Days

Secondary Outcome

Outcome	TimePoints
Dhatri Toyum is effective in Garbhini Chardi	7 Days

Target Sample Size

Total Sample Size="68"
Sample Size from India="68"
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)

15/11/2021

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

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The onset of emesis gravidarum is one of the most physiological changes occurring among early pregnant women. To evaluate and establish easy safer a cost effective ayurvedic remedy for garbhini chardi.