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CTRI Number  CTRI/2022/11/047177 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 10/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Study of effect of Oral Glutathione Capsule for skin Lightening in subjects with dark skin 
Scientific Title of Study   An Open-Label, Single-Arm, Prospective Clinical Study to Evaluate Efficacy and Safety of Oral Glutathione capsule as a skin-lightening agent in Subjects with dark skin and Hyperpigmentation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GHPL-GLT-22-01 Version No. 1.0 Dated 6-May-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bangaru H 
Designation  Principal Investigator 
Affiliation  K R Hospital 
Address  Department of Dermatology K R Hospital, Irwin Rd
Devaraja Mohalla, Yadavagiri, Mysuru, Karnataka
Mysore
KARNATAKA
570001
India 
Phone    
Fax    
Email  drbangaruskin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  Alchemy Clinical Research Services 
Address  Room No 3, First Floor, Alchemy Clinical Research Services, 38, LIG So.
Somalwada Road, Manish Nagar
Nagpur
MAHARASHTRA
440015
India 
Phone  9822371703  
Fax    
Email  drabhijit@alchemyclinical.in  
 
Details of Contact Person
Public Query  
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  Alchemy Clinical Research Services 
Address  Room No 3, First Floor, Alchemy Clinical Research Services, 38, LIG So.
Somalwada Road, Manish Nagar
Nagpur
MAHARASHTRA
440015
India 
Phone  9822371703  
Fax    
Email  drabhijit@alchemyclinical.in  
 
Source of Monetary or Material Support  
Gangwal Healthcare Pvt Ltd 
 
Primary Sponsor  
Name  Gangwal Healthcare Pvt Ltd 
Address  705, Quantum Towers Quantum Tower, Rambagh Lane, behind State Bank of India, Malad, Nadiyawala Colony 2, Malad West, Mumbai, Maharashtra 400064 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Bangaru H  KR Hospital  Department of Dermatology K R Hospital Irwin Road Mysore
Mysore
KARNATAKA 		 8971832402

drbangaruskin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee. Mysore Medical College & Research Institute and Associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glutathione  Glutathione capsule 600 mg OD for 30 Days 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy Volunteers, men or women, from 18 to 60 years old.
2. Having given their written, free and informed consent.
3. Healthy subjects with skin type Fitzpatrick IV and V.
4. Working indoor office jobs (for minimum 8 hours). 
 
ExclusionCriteria 
Details  1. Personal or family history of skin cancer, especially melanoma.
2. Consumption of any preparations containing glutathione within 1 month of enrolment.
3. Use of any topical skin brightening or whitening preparations within 1 month of enrolment.
4. Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas.
5. A pregnant or breastfeeding mother.
6. Personal history of drug allergy or skin disorder due to side effects of oral therapy.
7. Alcoholics and subjects with substance abuse.
8. Subjects who have participated in other trial within last 3 months.
9. Any other condition which the principal investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The percentage of subjects with Skin lightening over baseline at least one tone light at 30 days of treatment using Fitzpatrick scale the from baseline visit to end of treatment visit.  Day 1 to Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
The numbers of subjects with Decreased Melanin Index  Day 1 to Day 30 
Mean change in Liver function test   Day 1 to Day 30 
Mean change in Melanin indices  Day 1 to Day 30 
Mean change in Plasma Glutathione level  Day 1 to Day 30 
Overall improvement in Skin tone by Physician’s Global Assessment  Day 1 to Day 30 
Overall improvement in Skin tone by Patient’s Global Assessment  Day 1 to Day 30 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   14/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is designed as Open label, single arm, prospective, interventional and observational study. All the subjects will receive Glutathione capsule 600 mg as a test product. Subjects fulfilling the inclusion and exclusion criteria will be enrolled in the study. Enrolled subjects will be under treatment for 4 weeks, following up at day 15 and day 30.

Parameters of Skin tone and Melanin indices and quality of life questionnaires will be assessed at baseline and at day 30. Safety parameters like hematology and biochemistry will be assessed at baseline and at day 30.

 
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