| CTRI Number |
CTRI/2025/08/093431 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Oziva Bioactive Gluta Fizzy Effervescent Tablets in people with facial dark spots such as pimple marks, sunspots, age spots, and uneven skin tone. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Two-Arms, Prospective, Single-Center Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Test Product i.e. Oziva Bioactive Gluta Fizzy in Subjects with Facial Hyperpigmentation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250030-ZV_1.0_06Aug25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Zywie Ventures Private Ltd Plot No. 53, Near Metal Power Analytical, Marol, Andheri East-Mumbai– 400059, Maharashtra, Ind |
|
|
Primary Sponsor
|
| Name |
Zywie Ventures Private Ltd |
| Address |
Plot No. 53, Near Metal Power Analytical, Marol, Andheri East-Mumbai – 400059,Maharashtra, India |
| Type of Sponsor |
Other [Nutraceutical Industry-Indian] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
313, Silver Radiance-4, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
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 |
NIL |
NA
|
| Intervention |
Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g |
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends.
Frequency: Once Daily
Route of administration: Oral
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
The total duration of the intervention agent is 90 days
|
| Intervention |
Placebo Effervescent Tablets 4.1 g |
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends.
Frequency: Once Daily
Route of administration: Oral
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
The total duration of the intervention agent is 90 days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 21 to 55 years (both inclusive) at the time of consent.
2) Sex: Adult male and female having facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face.
3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
4) Subjects with Fitzpatrick Skin Types III to VI, indicating moderate to dark skin tones.
5) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
6) Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
7) Subjects are not allowed to participate in any other study until this study is complete.
8) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
9) Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
10) Subjects must agree to record medication use during the study
|
|
| ExclusionCriteria |
| Details |
1) Subjects who are on steroids for last six months.
2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
4) Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
5) Subjects that are pregnant and/or breastfeeding.
6) The subject has a known allergy or sensitivity to product ingredients.
7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
8) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
9) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
11) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test product by assessing change in pigmentation and dark spots from baseline to post- product, within each product group and across product groups.
2. To evaluate the effectiveness of the test product by assessing improvement in skin radiance from baseline to post-product, within each product group and across product groups.
|
1. To evaluate the effectiveness of test products by assessing change in skin pigmentation and dark spots using Mexameter® MX 18 from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups.
2. To evaluate the effectiveness of test products by assessing change in skin radiance using skin Glossymeter from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of the test product by assessing change in skin elasticity and firmness from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 2. To evaluate the effectiveness of the test product by assessing change in skin hydration from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 3. To evaluate the effectiveness of the test product by assessing change in oxidative stress markers – Superoxide Dismutase (SOD) from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 4. To evaluate the effectiveness of the test product by assessing change in inflammatory markers such as C-Reactive Protein and Interleukin-6 (IL-6) from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 5. To evaluate the effectiveness of the test product by assessing change in skin colour parameters — L, a, b, and ITA from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 6. To evaluate the effectiveness of the test product by assessing changes in spot colour intensity, average size and number, pigmentation intensity and contrasts from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 7. To evaluate the effectiveness of the test product by assessing changes in pigmentation intensity in terms of spots surface and skin radiance from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 8. To evaluate the effectiveness of the test product by assessing changes in melasma severity from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 9. To evaluate the effectiveness of the test product by assessing changes in facial photographs from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
| 10. To evaluate the effectiveness of the test product by assessing changes in product perception questionnaire from baseline to post-product, within each product group and across product groups. |
At baseline on Day 01, Day 45 and Day 90 |
|
|
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)
|
02/09/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a randomized,
double-blinded, single-centre, two-arms, placebo-controlled, prospective study
to evaluate clinical safety, efficacy and in-use tolerability of Test Product
i.e. Oziva Bioactive Gluta Fizzy Effervescent tablets in
subjects with facial hyperpigmentation and dark spots.
A total of 60 Indian
Subjects (30 Subjects per Test Product), including males and non-pregnant,
non-lactating females aged between 21 and 55 years (inclusive). Indian Subjects
with a Fitzpatrick skin type of III to VI must present with facial
hyperpigmentation and dark spots such as
tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face
at baseline. Participants will be randomized in a ratio to received either
test Product A or test Product B. the study aims to complete evaluation for 50
Indian Subjects (25 Subjects per Test Product).
The potential subjects
will be screened as per the inclusion and exclusion criteria only after
obtaining written informed consent from the subjects. Subjects will be
contacted telephonically by recruiting department prior to the screening.
There will be total of 3
visits during the study. The duration of the study will be 90 Days (12 weeks)
from the enrolment. Subjects will be instructed to visit the facility as per below
visits:
Visit: 01
(Day 01, Week 00): Screening, ICD obtained,
Enrolment, Baseline readings. Visit 02 (Day
45, Week 06): Product Phase, Evaluations Visit 03 (Day
90, Week 12): Evaluations and Product Phase end | End of Study |