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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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