CTRI

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CTRI Number

CTRI/2025/03/081664 [Registered on: 05/03/2025] Trial Registered Prospectively

Last Modified On:

05/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Clinical Trial on the Structure and Functions of Skin: Pathophysiology of Shwitra and Management by Indigenous Drugs.

Scientific Title of Study

Structure And Functions Of Skin With Special Reference To Pathophysiology Of Shwitra And Its Management By Some Indigenous Drugs.

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Pooja Pandey
Designation	PG Scholar
Affiliation	Government Ayurvedic College and Hospital kadamkuan Patna
Address	Department of Rog Nidan evam Vikriti Vigyan, Government Ayurvedic College and Hospital kadamkuan Patna Aryabhatta Knowledge University Patna Patna BIHAR 800003 India
Phone	8368570738
Fax
Email	pooja.p2609@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Amarendra Kumar Singh
Designation	Associate professor
Affiliation	Government Ayurvedic College and Hospital kadamkuan Patna
Address	Department of Rog Nidan evam Vikriti Vigyan, Government Ayurvedic College and Hospital kadamkuan Patna Aryabhatta Knowledge University Patna Patna BIHAR 800003 India
Phone	9931230820
Fax
Email	singh.amrendra70@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Amarendra Kumar Singh
Designation	Associate professor
Affiliation	Government Ayurvedic College and Hospital kadamkuan Patna
Address	Department of Rog Nidan evam Vikriti Vigyan, Government Ayurvedic College and Hospital kadamkuan Patna Aryabhatta Knowledge University Patna Patna BIHAR 800003 India
Phone	9931230820
Fax
Email	singh.amrendra70@yahoo.co.in

Source of Monetary or Material Support

Government Ayurvedic College and Hospital Kadamkuan Patna Bihar

Primary Sponsor

Name	Government Ayurvedic College and Hospital Kadamkuan Patna
Address	Department Rog Nidan evam Vikriti Vigyan, Government Ayurvedic College and Hospital Kadamkuam Patna
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 Pooja Pandey	Government Ayurvedic College And Hospital	Department of Rog Nidan Evam Vikriti Vigyan Government Ayurvedic College And Hospital Patna Bihar 800003 Patna BIHAR	8368570738 pooja.p2609@gmail.com

Details of Ethics Committee

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

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L80\|\|Vitiligo. Ayurveda Condition: KUSHTHAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: 1. Bakuchi churna 2. Bhringraj churna 3. Chitrak churna 4. Udumbar churna, Reference: 1. - Bhaisajya Ratnawali 54/55 2. - Ashtanga Hridya Chikitsa 20/8 3. - Charak Chikitsa 7/84-85 4. - Charak Chikitsa 7/162, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 80(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	15.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. The patients having age between 15 to 70 years. 2. The patient’s sign and symptom should be based on both ayurvedic as well as modern view.

ExclusionCriteria

Details

1.Age above 70 and less than 15 years.
2.Immunocompromised patients e.g. HIV etc.
3.Severe deformities.
4.Pregnant and lactating women not included in this study.
5.Patients are unwilling.
6.Patient with complicated associated symptoms i.e. severely ill e.g. liver cirrhosis, adenocarcinoma.

Method of Generating Random Sequence

Adaptive randomization, such as minimization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Mandal( size of lesion) 2.Aruna 3.Rukshata 4.Paridaha 5.Romavidhvanshi 6.Bahal 7.Itching. 8.% of area involvement	The assessment of patient will be done at the interval of 15 days during the treatment.

Secondary Outcome

Outcome	TimePoints
Hb% and ESR	The assessment of patient will be done at the interval of 15 days.

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

01/04/2025

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

This study is open label single arm clinical trial to determine the efficacy of Bakuchi, Bhringraj, Chitrak, Udumbar in Shwitra for the age group of 15-70 years for 60 days. The study will be conducted in Government Ayurvedic College and Hospital Kadamkuan Patna Bihar on 36 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD level of PG Department of Rog Nidan. The assessment will be done at interval of 15 days of clinical trial and result obtained will be tabulated and statistically analyzed usin appropriate test.