| CTRI Number |
CTRI/2021/10/037519 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF ARAGVADHADYAM TAILAM AND DHATRI KHADIR KWATH ON VITILIGO |
|
Scientific Title of Study
|
A PHARMACEUTICO-CLINICAL STUDY OF ARAGVADHADYAM TAILAM AND DHATRI KHADIR KWATH ON SHVITRA WITH SPECIAL REFRENCE TO VITILIGO |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MUKESH KUMAR |
| Designation |
MD(AY) SCHOLAR |
| Affiliation |
goverment ayurvedic college,patna |
| Address |
GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL ,WEST LOHANIPUR,BUDHHA MURTI, PATNA
Patna
BIHAR
800003
India |
| Phone |
9835839715 |
| Fax |
|
| Email |
mukeshkr8088@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEETU SINGH |
| Designation |
ASST.PROFFESOR |
| Affiliation |
goverment ayurvedic college,patna |
| Address |
GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL ,WEST LOHANIPUR,BUDHHA MURTI, PATNA
Patna
BIHAR
800003
India |
| Phone |
7091141115 |
| Fax |
|
| Email |
singhneetu17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEETU SINGH |
| Designation |
ASST.PROFFESOR |
| Affiliation |
goverment ayurvedic college,patna |
| Address |
GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL ,WEST LOHANIPUR,BUDHHA MURTI, PATNA
Patna
BIHAR
800003
India |
| Phone |
7091141115 |
| Fax |
|
| Email |
singhneetu17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College Patna |
|
|
Primary Sponsor
|
| Name |
GOVERMENT AYURVEDA COLLEGE AND HOSPITAL PATNA |
| Address |
GOVERMENT AYURVEDA COLLEGE AND HOSPITAL,WEST LOHANIPUR,BUDHHA MURTI,KADAMKUAN,PATNA |
| Type of Sponsor |
Government medical college |
|
|
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 MUKESH KUMAR |
Government Ayurvedic College Hospital Patna |
Department of Research (Rasa Sashtra and Bhaishajya Kalpana), OPD Room No: 10, Government Ayurvedic College and Hospital Patna, Kadamkuan, Near Buddh Murthi, Bihar 800003
Patna
BIHAR |
9835839715
mukeshkr8088@gmail.com |
|
|
Details of Ethics Committee
|
| 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:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatri khadir kwath, Reference: chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Bakuchi churna taken with Dhatri khadir kwath(2) Medicine Name: Aragvadhadyam tailam, Reference: Chakradutta, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: for external application as per requirement(3) Medicine Name: Dhatri khadir kwath and Aragvadhadyam tailam, Reference: Chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Dhatri khadir Kwath should be taken with Bakuchi churna and Aragvadhadyam tailam should be used topical |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing for trial, having signs and symptoms (classical along with some modern parameters). |
|
| ExclusionCriteria |
| Details |
Patients suffering from AIDS, Cancer, TB, Cardiac complications, patients of Sprue disease, Malabsorption, HB% below 7gm/dl, pregnant women. Vitiligo patches that rapidly spread and become associated with redness, blister formation, itching during therapy or as such. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Shvitra. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Shvitra. |
Evaluation will be done after 90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/10/2021 |
| Date of Study Completion (India) |
02/06/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shvitra is considered as one of the varieties of Kushtha, that can be correlated with Vitiligo based on the similarities of signs and symptoms. It is caused due to the vitiation of tridosha and dhathus like rasa, rakta, mamsa and meda. Dhatri khadir kwath and Aragvadhadyam tailam yoga are formulations described in chapter Kushtha Chikitsa of Chakradutta for Shvitra, are selected for the present study. |