CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/03/082951 [Registered on: 20/03/2025] Trial Registered Prospectively

Last Modified On:

19/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Compare the effect of Mustakadi churna and Chavyadi churna in Grahani Roga w.s.r to Irritable Bowel Syndrome.

Scientific Title of Study

A comparative clinical study of Mustakadi churna and Chavyadi churna in the management of Grahani Roga w.s.r to Irritable Bowel Syndrome.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pankaj Kumar Singh
Designation	MD(Ay.) Scholar(Kayachikitsa)
Affiliation	Government Ayurvedic College and Hospital, Kadamkuan Patna
Address	Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna Patna BIHAR 800003 India
Phone	8051301633
Fax
Email	pankajdmc101@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vijay Bahadur Singh
Designation	Associate Professor and Head of Department, Department of Kayachikitsa
Affiliation	Government Ayurvedic College and Hospital, Kadamkuan, Patna
Address	Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna Patna BIHAR 800003 India
Phone	7004642738
Fax
Email	vijay.md09@gmail.com

Details of Contact Person
Public Query

Name	Dr Vijay Bahadur Singh
Designation	Associate Professor and Head of Department, Department of Kayachikitsa
Affiliation	Government Ayurvedic College and Hospital, Kadamkuan, Patna
Address	Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna Patna BIHAR 800003 India
Phone	7004642738
Fax
Email	vijay.md09@gmail.com

Source of Monetary or Material Support

Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India. Pin-800003

Primary Sponsor

Name	Dr Pankaj Kumar Singh
Address	Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India. Pin-800003
Type of Sponsor	Other [Self]

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 Pankaj Kumar Singh	Government Ayurvedic College and Hospital, Kadamkuan, Patna	OPD No. 9, Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna Patna BIHAR	8051301633 pankajdmc101@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee, Government Ayurvedic College, Kadamkuan, Patna	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K582\|\|Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Chavyadi churna, Reference: Yogaratnakara, Grahanichikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Mustakadi churna, Reference: Bhavaprakash Madhyakhand, Grahani Rogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -

Inclusion Criteria

Age From	16.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Clinical features suggesting Grahani Roga. 2. Patient willing for the research trial.

ExclusionCriteria

Details

1. Age below 16 years and above 60 years.
2. Patients with major ailments like serious Heart disease, uncontrolled Diabetes mellitus,
AIDS, Blood mixed with stool, Ascites, Tuberculosis, Malignancy etc.
3. Patients with any major surgery of GI tract.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
The improvement in the patients will be assessed mainly on the basis of relief in the symptoms of disease like Muhurbaddha Muhurdrava Mala pravriti, Udara Shoola, Shleshma mala pravriti, Shoonpaadkara, Asthiparvaruk, Lohaamagandhi-tiktamla Udgaar, Atopa, Arochak, Trishna, Alasya.	45 days

Secondary Outcome

Outcome	TimePoints
Stool for occult blood, mucus, ova and cyst. Complete blood count	45 days

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 2

Date of First Enrollment (India)

01/04/2025

Date of Study Completion (India)

13/10/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

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 study is Randomized parallel group open label interventional trial to compare the effects of Mustakadi churna and Chavyadi churna in the management of Grahani Roga with special reference to Irritable Bowel Syndrome in two group of 30 patients in each group. This study will be conducted in Government Ayurvedic College and Hospital, Patna, Bihar in the Department of Kayachikitsa. Follow up will be done every 15 days for total duration of study i.e. of 45 days.