CTRI Number |
CTRI/2022/04/041617 [Registered on: 04/04/2022] Trial Registered Prospectively |
Last Modified On: |
30/03/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Unani Other (Specify) |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Efficacy of Unani drugs on Melasma |
Scientific Title of Study
|
A Comparative Clinical Study on the Efficacy of Joshanda
Haleela Siyah with Tila-e-Tukhm Turb and Tukhm Jarjir vs
Tukhm Kharpazah and Aard Baqla in Kalaf (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 Tuba Hanif Zulfar |
Designation |
PG Scholar |
Affiliation |
National Institute of Unani Medicine |
Address |
Department of Amraz e Jild Wa Tazeeniyat
National Institute of Unani Medicine
Kottegepalya Magadi Main Road Bengaluru
Bangalore KARNATAKA 560091 India |
Phone |
9987159752 |
Fax |
|
Email |
tubazulfar786@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Tuba Hanif Zulfar |
Designation |
PG Scholar |
Affiliation |
National Institute of Unani Medicine |
Address |
Department of Amraz e Jild Wa Tazeeniyat
National Institute of Unani Medicine
Kottegepalya Magadi Main Road Bengaluru
Bangalore KARNATAKA 560091 India |
Phone |
9987159752 |
Fax |
|
Email |
tubazulfar786@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mohd Aleemuddin Quamri |
Designation |
Professor |
Affiliation |
National Institute of Unani Medicine |
Address |
Department of Amraz e Jild Wa Tazeeniyat
National Institute of Unani Medicine
Kottegepalya Magadi Main Road Bengaluru
Bangalore KARNATAKA 560091 India |
Phone |
9341072974 |
Fax |
|
Email |
drmaquamri@gmail.com |
|
Source of Monetary or Material Support
|
Room No. 4 Skin OPD National Institute of Unani Medicine Hospital |
|
Primary Sponsor
|
Name |
National Institute of Unani Medicine |
Address |
OPD No 04 Department of Amraze Jild Wa Tazeeniyat National Institute of Unani
Medicine Bengaluru |
Type of Sponsor |
Research institution and hospital |
|
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 Tuba Hanif Zulfar |
Room No. 4 Skin OPD National Institute of Unani Medicine |
Room No. 4 Skin OPD National Institute of Unani Medicine Kottigepalya Magadi
Main Road Bengaluru 560091 Bangalore KARNATAKA |
9987159752
tubazulfar786@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee for Biomedical Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Haleela Siyah
Ard Baqla and Tukhme Kharpazah |
Haleela Siyah 10g Ard Baqla 5g and Tukhme Kharpazah 5g
10 gm of Haleela Siyah will be soak overnight in 150 ml of water and its Decoction will be drink once in morning before meal for 2 weeks in both Group Prior to the application of Tila Fomentation of hot water to be taken for 10 minutes Then Safoof of Tila Ard Baqla and Tukhme Kharpazah mixed in the normal water and applied on the affected site of face by means of facepack brush for 20 minutes once in a day for 3 weeks in Group B |
Intervention |
Haleela Siyah
Tukhme Turb and Tukhme Jarjir |
Haleela Siyah 10g
Tukhme Turb 5g
Tukhme Jarjir 5g
10 gm of Haleela Siyah will be soak overnight in 150 ml of water and its Decoction will
be drink once in morning before meal for 2 weeks in both Group
Prior to the application of Tila Fomentation of hot water to be taken for 10 minutes. Then Safoof of Tilae
Tukhme Turb and Tukhme Jarjir mixed in the normal water and applied on the affected site of face by means
of facepack brush for 20 minutes once in a day for 3 weeks in Group A |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with Fitzpatrick Skin phototype 3rd to 6th
Patients m MASI Score up to Marked in Darkness (0-3) and ≤ 49 % in Area
Duration of Melasma ≤ 3 Yrs.
Patient willing for study |
|
ExclusionCriteria |
Details |
Pregnant and Lactating women
Patients with systemic disease e.g. Malignancy, Thyroid Dysfunction, CKD, Tuberculosis.
History of any Skin therapies related to Hyperpigmentation
History of Hypersensitivity Reaction with Drugs.
Severe Cases of Melasma |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reversal of mMASI, PGA, PtGA, scores
Change in photographic lesion |
28 days |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
09/04/2022 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
Diagnosed cases of Melasma fulfilling the inclusion criteria
will be enrolled into clinical trial after obtaining
written informed consent, then they will be randomly allocated into two groups
each 23; viz Group A will receive
local application of Tila of Tukhme Turb and Tukhme Jarjir and Group B Tila
of Aad Baqla and Tukhme
kharpazah, both groups will be given Joshanda Haleela Siyah orally along
with hot water vapors fomentation.
Assessment of outcome will be carried out with m-MASI Score and pGA Scale
, photography of the lesions and Dermoscopy on 0 (baseline) 7th , 14th and on 21th day of the trial followed by Post trial follow u will made on 28th day to find
out any residual effect of the therapy. Drug
safety will be ensured by monitoring the haematological and serological
indicators. Efficacy analysis will be performed on Intention-to-treat (ITT)
basis using the last observation carry forward method
(LOCF) on participants those received all the doses
of both test and comparator drugs and underwent at least two assessment post baseline. The study data will be analyze statistically with appropriate test. P
values of last than 0.05 will be considered statistically significant . |