CTRI

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CTRI Number

CTRI/2026/03/105091 [Registered on: 02/03/2026] Trial Registered Prospectively

Last Modified On:

28/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

A Study to See Whether Gokshur Siddha Ghrita Taken in the Sixth Month of Pregnancy Helps Prevent Swelling in Pregnant Women.

Scientific Title of Study

A Clinical Study of Gokshur Siddha Ghrita During 6th Month Of Pregnancy As a Prevantion Of Garbhini Shotha

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 Prabha kumari
Designation	Assistant professor, Head of department
Affiliation	Government Ayurvedic college and Hospital, patna
Address	Department of Prasuti tantra evum Stri roga, Government Ayurvedic college and hospital kadamkuan Patna Aryabhatta knowledge university,patna Patna BIHAR 800003 India
Phone	7004860634
Fax
Email	dr.prabhapandey@yahoo.in

Details of Contact Person
Scientific Query

Name	Dr Prabha Kumari
Designation	Associate Professor and HOD
Affiliation	Government Ayurvedic college and Hospital Patna
Address	Department of Prasuti Tantra evum Stri Roga Government Ayurvedic College and Hospital Kadamkuan Patna Bihar Patna BIHAR 800003 India
Phone	7004860634
Fax
Email	dr.prabhapandey@yahoo.in

Details of Contact Person
Public Query

Name	Dr Prabha Kumari
Designation	Associate Professor and HOD
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Prasuti Tantra evum Stri Roga Government Ayurvedic College and Hospital Kadamkuan Patna Bihar Patna BIHAR 800003 India
Phone	7004860634
Fax
Email	dr.prabhapandey@yahoo.in

Source of Monetary or Material Support

Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003

Primary Sponsor

Name	Government Ayurvedic College Hospital Patna Bihar
Address	Department of Prasuti evum Stri Roga Government Ayurvedic College and Hospital Kadamkuan Patna Aryabhatta Knowledge University Patna Bihar 800003
Type of Sponsor	Government 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
Dr Chandra Prakash Kumar	Government Ayurvedic college and hospital kadamkuan Patna	Department of Prasuti Tantra evum Stri Roga Government Ayurvedic College kadamkuan Patna Aryabhatta Knowledge University, bihar Patna BIHAR Patna BIHAR	8789216530 chandraprakashkumar3410@gmail.com

Details of Ethics Committee

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

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O120\|\|Gestational edema. Ayurveda Condition: GARBINIROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Gokshur Siddha Ghrita, Reference: Sharandhar Samitha ,Madhyamkhand,2/164, Page no.159, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Usana jal or Yavagu), Additional Information: .

Inclusion Criteria

Age From	19.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	The sign symptoms based on both Ayurvedic as well as Modern. view The age group of patients will be between 19 to 35 years. Pregnant Women of(20 weeks-24 weeks)

ExclusionCriteria

Details

Women below 18 yrs of age or over 35 yrs above primigravida.
Pregnancy associated with medical condition eg:- cardiovascular disease , kidney disease , diabetes, tuberculosis, liver disease and endocrine disease (hypothyrodism and hyperthyrodism).

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Clinical study to evalauate the efficacy of Gokshur siddha ghrita in the management of 6th Month Of Pregnancy as a Prevention of Garbhini Shotha	2 Month

Secondary Outcome

Outcome	TimePoints
To study the Ayurvedic and modern concept about 6th Month Of Pregnancy as a Prevention of Garbhini Shotha.	2 Month

Target Sample Size

Total Sample Size="35"
Sample Size from India="35"
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)

12/03/2026

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="0"
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

Generally, show that up to 80 percentage of pregnant woman suffering from pitting edema. In Sushruta Samhita of Ayurved, shoth in pregnancy is specially described in the concept of Garbhinivyadhi (disorder in pregnancy) early detection and appropriate treatment reduce the edema and to prevent the complication arising due to severe edema. Such disorders are often serious. They include the following deep vein thrombosis Pre Eclampsia, eclampsia, anemia, peripartum cardiomyopathy (heart failure that develops late in pregnancy or often delivery), hypertension, renal disorder. In Sushruta sharir sthan we find the reference of gokshur siddha Ghrita. Mainly indicated in prevention of Garbhini shoth, Shoth is especially on feet and face on 6th -7th month of pregnancy. The administration of his drug would be beneficial in edema related to pregnancy in 6th and 7th month of pregnancy there is swelling on leg and face of mother. Mainly the Gokshur is diuretic in nature and Ghrita is vishnashak in nature hence it is used in Garbhinshoth during 6th month of pregnancy.