| CTRI Number |
CTRI/2022/07/043645 [Registered on: 01/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of Aragwadha Pushpa Lepa in the management of Vyanga with special reference to Melasma |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Aragwadha Pushpa Lepa (Cassia fistula Linn.) in the management of Vyanga with special reference to Melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nanditha M |
| Designation |
MD Student |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
2nd year PG scholar,
Department of Dravyaguna,
Sri Sri College of Ayurvedic Science and Research,
Kanakapura road, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9036345368 |
| Fax |
|
| Email |
nandithabhavana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh C D |
| Designation |
Guide & Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Professor,
Department of Dravyaguna,
Sri Sri College of Ayurvedic Science and Research,
Kanakapura road, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
8073119372 |
| Fax |
|
| Email |
drmaheshcd@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanditha M |
| Designation |
MD Student |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
2nd year PG scholar,
Department of Dravyaguna,
Sri Sri College of Ayurvedic Science and Research,
Kanakapura road, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9036345368 |
| Fax |
|
| Email |
nandithabhavana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura road, Bangalore 560082 |
| Type of Sponsor |
Private 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 Nanditha M |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of KC 3,
Sri Sri College of Ayurvedic Science and Research Hospital,
Kanakapura road, Bangalore
Bangalore
KARNATAKA |
9036345368
nandithabhavana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. 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: Aragvadha Pushpa, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Folklore reference | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varnya Dashemani, Reference: Charaka Samhita, Sutra Sthana, 4th chapter, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects fulfilling the diagnostic criteria of Vyanga with special reference to Melasma will be randomly selected, irrespective of their religion, occupation and socio-economic status |
|
| ExclusionCriteria |
| Details |
1) Female on oral contraceptive pills, pregnant women and lactating women
2) Who are on any hormonal therapy
3) Known hyperpigmentation since birth
4) Known inflammatory pigmentation
5) Known malignant melanoma
6) Any other condition interfering with the course of the treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved uniformity in colour of facial skin |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in number of hyper pigmented lesions over facial skin |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/07/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, active controlled trail comparing the efficacy of Aragwadha Pushpa Lepa and Varnya Dashemani Lepa for 30 days in 30 patients with Vyanga (Melasma) that will be conducted at Sri Sri College of Ayurvedic Science and Research, Kanakapura road, Bangalore. Both subjective and objective criteria are used for assessment in the study. This study might reduce the necessity of usage of 10 drugs to using 1 drug in the condition of Vyanga (Melasma). |