| CTRI Number |
CTRI/2023/03/050874 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of navneet gudadi lepa in vyanga(melasma) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Navneet Gudadi Lepa in the management of Vyanga(Melasma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gangarapu Kiranmai |
| Designation |
MD PG scholar |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Research center. |
| Address |
Panchakarma Department OPD No.9 DR. D. Y. Patil College of
Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune,
Maharashtra, India.
Pune
MAHARASHTRA
411018
India |
| Phone |
6301936796 |
| Fax |
|
| Email |
kirru1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali r chaudhari |
| Designation |
MD Panchkarma |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Research center. |
| Address |
DR.D.Y.Patil College of Ayurved and Research center, Sant tukaram nagar, Pimpri, Pune, Maharastra, India. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishalidhandes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gangarapu Kiranmai |
| Designation |
MD PG Scholar |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Research center. |
| Address |
Panchakarma Department OPD No.9 DR. D. Y. Patil College of
Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune,
Maharashtra, India.
Pune
MAHARASHTRA
411018
India |
| Phone |
6301936796 |
| Fax |
|
| Email |
kirru1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of Ayurveda and Research centre, Pimpri |
|
|
Primary Sponsor
|
| Name |
Dr. Gangarapu Kiranmai |
| Address |
Sant tukaram nagar, pimpri, pune, Maharastra. 411018 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vaishali R chaudhari |
Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gangarapu Kiranmai |
Dr D.Y.Patil college of Ayurveda and Research Centre, |
Department of Panchkarma OPD no 9 Dr. D.Y. Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018
Pune
MAHARASHTRA |
6301936796
kirru1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: shabdha kalpa druma, Procedure details: lepa is applying the paste of drugs on the affected area in the opposite direction of hair follicle for the easy absorption of the drug. Duration applied for 7days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-60 years irrespective of their sex, occupation and religion.
Having symptoms of vyanga like niruja(painless), tanu(thin), shyava varna(blackish patch).
|
|
| ExclusionCriteria |
| Details |
Known case of any skin malignancy.
Any skin allergy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in symptoms like darkness and area reduction in the affected area of skin |
7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvemant of homogenity and darkness of affected skin. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/04/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is A Clinical study to evaluate the effect of Navneet Gudadi lepa in the management of Vyangh (Melasma)
Study design is Single arm clinical study
Total 34 patients will be enrolled
Assessment of patients on 1st and 7th day
Total duration of study will be 18 months. |