FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/107035 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 28/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Oral Glutathione on Skin Pigmentation and Skin Health in Healthy Adults. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of liposomal glutathione (LipogloTM) and non-liposomal oral glutathione formulations on skin pigmentation and barrier function in healthy adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Chakkarwar 
Designation  Director 
Affiliation  InventaLife Research Solutions Pvt. Ltd.  
Address  40, Golden City Center, Besides Prozone Mall, Chhatrapati Sambhajinagar (Aurangabad), Maharashtra, India.

Aurangabad
MAHARASHTRA
431006
India 
Phone  7588590417  
Fax    
Email  vishal@inventalife.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Sravani T  
Designation  Manager - Technical 
Affiliation  Botanic Healthcare Pvt. Ltd. 
Address  TSIIC Industrial Development Area, Nacharam Village, Uppal Mandal, Hyderabad, Rangareddy, Telangana, India

Hyderabad
TELANGANA
500076
India 
Phone  7995688815  
Fax    
Email  research1@botanichealthcare.net   
 
Details of Contact Person
Public Query  
Name  Dr H N Shivaprasad  
Designation  Director 
Affiliation  Botanic Healthcare Pvt. Ltd. 
Address  TSIIC Industrial Development Area, Nacharam Village, Uppal Mandal, Hyderabad, Rangareddy, Telangana, India

Hyderabad
TELANGANA
500076
India 
Phone  9515222461  
Fax    
Email  shiv@botanichealthcare.net   
 
Source of Monetary or Material Support  
Botanic Healthcare Pvt. Ltd. TSIIC Industrial Development Area, Nacharam Village, Uppal Mandal, Hyderabad, Rangareddy, Telangana-500076, India  
 
Primary Sponsor  
Name  Botanic Healthcare Pvt. Ltd.  
Address  TSIIC Industrial Development Area, Nacharam Village, Uppal Mandal, Hyderabad, Rangareddy, Telangana-500076, India  
Type of Sponsor  Other [Herbal Ingredient Manufactures] 
 
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 Shamsunder Agarwal   Target Institute of Medical Education and Research Pvt. Ltd   Department of Clinical Study, Second floor, OPD no 1, E 203, Jaymala Business Court, Besides Satyam Prima, Takle Nagar, Manjri BK. Hadapsar Pune 412307 Pune, MAHARASHTRA
Pune
MAHARASHTRA 		 9422026123

drshaam@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kusum Independent Ethics Committee, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin pigmentation and skin barrier function 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liposomal Glutathione (LipogloTM)  Each capsule contains 500 mg liposomal glutathione (LipogloTM), administered orally once daily after a meal for 84 days. 
Comparator Agent  Non-Liposomal Glutathione  Each capsule contains 500 mg non-liposomal glutathione, administered orally once daily after a meal for 84 days.  
Comparator Agent  Placebo  Each capsule containing 0 mg active glutathione, administered orally once daily after meal for 84 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Healthy individuals who are able to understand all the information provided and who give written informed consent.
2. The study will include healthy participants aged between 20 and 50 years.
3. Eligible subjects will have skin types IV or V according to the Fitzpatrick scale.
4. Participants engaged in indoor office-based occupations for at least 8 hours per day
5. Subject with facial melanin index ranging between 200 and 350 will be included in the study.
6. Non-smoker participants included in the study
7. All participants will be confirmed to be in good health based on medical history, physical examination, and clinical laboratory evaluations, including serological, haematological, and biochemical assessments.
 
 
ExclusionCriteria 
Details  1. History of skin cancer in the participant or close family members, particularly melanoma.
2. Use of oral glutathione supplements within one month before study enrolment
3. Use of topical skin-brightening or whitening products within one month before enrolment
4. Presence of skin conditions or pigmentation disorders that may affect study assessments
5. Pregnant or breastfeeding women
6. History of allergy or hypersensitivity to oral medications
7. Presence of any major medical illness that may interfere with study participation
8. Abnormal liver function test results. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in skin pigmentation measured by facial melanin level using Mexameter   Baseline, week 2, week 4, week 8 and week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in skin colour parameters, including pigmentation and erythema using a Mexameter.  Baseline, week 2, week 4, week 8 and week 12. 
To assess changes in facial skin texture and appearance, including UV spots, pore characteristics, skin evenness, wrinkles, smoothness, and scaliness, using blinded dermatologist evaluation using subjective assessment and standardized facial photography along with ImageJ analysis.  Baseline, week 2, week 4, week 8 and week 12. 
To evaluate changes in skin barrier function measure using TEWL via Tewameter.  Baseline, week 2, week 4, week 8 and week 12. 
To assess changes in skin hydration using the Corneometer  Baseline, week 2, week 4, week 8 and week 12. 
To assess skin firmness and elasticity using the Cutometer  Baseline, week 2, week 4, week 8 and week 12. 
To assess subjective changes in skin properties, as reported by participants using a 4-point rating scale.  Baseline, week 2, week 4, week 8 and week 12. 
To evaluate changes in systemic glutathione status, including plasma reduced glutathione(GSH) and oxidized/protein-bound glutathione (GSSG and GSSP) levels, measured using a validated LC-MS method.  Baseline and week 12 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/04/2026 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Skin pigmentation concerns and compromised skin barrier function are common skin-related and quality-of-life issues among adults. Oxidative stress plays an important role in skin ageing and pigmentation changes. Oral glutathione supplementation is widely used for improving skin colour and skin health; however, conventional glutathione formulations may have limited bioavailability.

Liposomal glutathione (LipogloTM) is a novel formulation designed to improve oral absorption and systemic availability of glutathione. This randomised, double-blind, parallel-group, placebo-controlled study aims to evaluate the efficacy and safety of liposomal glutathione compared with non-liposomal glutathione and placebo in healthy adults.

The study will assess changes in skin pigmentation, skin colour, skin hydration, skin barrier function, and overall skin appearance. Safety will be evaluated through laboratory assessments and monitoring of adverse events. The study is intended to generate clinical evidence supporting the effectiveness and safety of oral glutathione formulations for improving skin pigmentation and skin health in healthy adults.

 
 
Close