CTRI Number |
CTRI/2021/01/030852 [Registered on: 29/01/2021] Trial Registered Prospectively |
Last Modified On: |
28/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Unani Other (Specify) [local application] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
skin aging treatment by unani formulation. |
Scientific Title of Study
|
Role of topical application of polyherbal formulation in photodamaged facial skin: An open label study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Chand Bibi |
Designation |
P.G. Scholar |
Affiliation |
National institute of unani medicine |
Address |
Dept of tahaffuzi wa samaji tib, NIUM, Kottigepalya, Magadi main road
Bangalore KARNATAKA 560091 India |
Phone |
8630103130 |
Fax |
|
Email |
ghanichand484@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Zarnigar |
Designation |
Professor |
Affiliation |
National institute of unani medicine |
Address |
Dept of tahaffuzi wa samaji tib,NIUM, Kottigepalya , Magadi main road
Bangalore KARNATAKA 560091 India |
Phone |
7022669959 |
Fax |
|
Email |
zarnigarriaz@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Chand Bibi |
Designation |
P.G. Scholar |
Affiliation |
National institute of unani medicine |
Address |
Dept of tahaffuzi wa samaji tib, NIUM, Kottigepalya, Magadi main road
Bangalore KARNATAKA 560091 India |
Phone |
8630103130 |
Fax |
|
Email |
ghanichand484@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Unani Medicine |
|
Primary Sponsor
|
Name |
National institute of unani medicine |
Address |
NIUM, Kottigepalya , magadi main road,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 Chand Bibi |
National Institute of Unani Medicine |
dept. of Tahaffuzi wa Samaji Tib, Magadi Main Road, Kottigepalya Bengaluru-560091 Bangalore KARNATAKA |
8630103130
ghanichand484@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: L578||Other skin changes due to chronicexposure to nonionizing radiation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Tretinoin 0.025% |
locally application once a day for 2 moths |
Intervention |
unani formulation of aarad e baqla, aarad e jau, aarad e nakhud, aarad e masoor equal part, tukhm e turb, khardal, haldi each one third part and kateera half part. |
15 gm powder mix into milk and apply it over face once a day for 2 months. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Having fine lines, wrinkles, hyper pigmentation
2. Moderate to advance facial skin aging
3. No known medical condition
4. Subject must sign a written informed consent |
|
ExclusionCriteria |
Details |
1. Subjects who are taking any medication which interfere with the test result.
2. Having history of skin cancer, melanoma , lupus, psoriasis, connective tissue disease.
3. Pregnant or planning pregnancy during study period, lactating, had given birth during the previous 6 months.
4. Acute or chronic allergy or history of hypersensitivity to cosmetics.
5. Smokers, having psychiatric disorder , hormone related and GIT disease.
6. Uncontrolled metabolic illness (e.g. diabetes mellitus, hypertension).
7. Having any skin procedure in previous 6 months (dermabrasion, chemical peel, botulinum toxin type A injection).
8. Subjects using anti aging skin care products. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1.Hydration.
2.Hyperpigmentation.
3.Dullness and roughness.
4.Coarse wrinkles. |
2 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Fine lines.
2.thickness.
3.Lusture of skin |
2 months |
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
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)
|
01/02/2021 |
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
|
Skin aging is a complex
biological process influenced by a combination of intrinsic and extrinsic
factors. Extrinsic aging is influenced by factors such as smoking, excessive
alcohol consumption, poor nutrition, and chronic exposure to the sun. Wrinkling
and pigmentary changes are directly associated with photo-aging. Asian skin
tends to tan more and burn less, which means that chronic UV exposure tends to
produce more pigmentation-related problems. There are several synthetic
skincare cosmetics existing in the market to treat premature aging and they
have so many adverse reactions too. Therefore a cheap, effective and safe
alternative is needed for the prevention of skin ageing. For the prevention of
skin aging, Unani physicians recommend the use of Jaali, mohammir and Mohsin al
lon drugs. In which aarad e baqla,
aarad e jau, aarad e nakhud, aarad e masoor, tukhm e turb, khardal, haldi and
kateera are selected for the study.
They have protein, fat, vitamin B complex, vitamin E, Mn, Cu, Zn, etc. as their
main constituents. These chemical constituents contribute to photoprotection by
increasing epithelialisation, smoothing the skin and stimulating collagen
synthesis. The drugs will be given in powder form, Kateera will be powdered separately and mixed into the whole
powder. Subjects will be advised to take 15 gm powder and mix into milk to form
a uniform paste then applied it on the face once a day for 2 month. On the
other hand control group will be given Tretinoin 0.025% cream & applied
locally once a day for 2 months. |