| CTRI Number |
CTRI/2024/05/066659 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Comprehensive study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Tanashi Cream and Vati on Vyanga |
|
Scientific Title of Study
|
A Comprehensive study of Tanashi Cream and Vati on Vyanga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand Kumar Chaudhary |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Rasashastra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9129221580 |
| Fax |
|
| Email |
anandayubhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Kumar Chaudhary |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Rasashastra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9129221580 |
| Fax |
|
| Email |
anandayubhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Gupta |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Rasashastra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7905432452 |
| Fax |
|
| Email |
vaishaligupta989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi, Uttar Pradesh 221005, India |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Institute of Medical Sciences,
Banaras Hindu University
Varanasi
Uttar Pradesh 221005
India |
| Type of Sponsor |
Research institution |
|
|
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 Vaishali Gupta |
Sir Sunderlal Hospital |
OPD No 11-B,
Department of Rasashastra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH |
7905432452
vaishaligupta989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tanashi Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tanashi Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Kumkumadi cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from classical clinical signs and symptoms of Vyanga.
Patients of either sex between 15-45 age group.
|
|
| ExclusionCriteria |
| Details |
Pregnant or breast feeding mother.
Patients receiving hormone or corticosteroid therapy.
Patients with history of endocrine disorders or allergies.
Chronicity more than 10 years.
Patients taking depigmenting or whitening products (oral or topical) within the previous 6 weeks will also a ground for exclusion.
Patients below 15 years and above 45 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the signs and symptoms of vyanga and establish the efficacy of Tanashi Cream and Vati |
within 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe reduction in Hyperpigmentation Area and Severity Index (HASI) score and formulate a good alternative to synthetic skin lightening cream |
within 1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
26/06/2024 |
| 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="4"
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
|
Several synthetic organic
skin-lightening agents are available in the market but they have limited use
because these agents may create adverse side effects on human skin. To overcome
these side effects, this herbo-mineral cream and vati namely Tanashi Cream and Tanashi Vati has been formulated as a medicine to reduce or cure the signs and symptoms associated with vyanga. |