| CTRI Number |
CTRI/2025/12/098803 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutraceutical ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the effect and Safety of immunity booster in Healthy Adults for Improvement in Immunity Hair Fall Skin Allergies and Pigmentation |
|
Scientific Title of Study
|
A SingleCenter Randomized DoubleBlind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Skinovate Blueberry immunity booster in Healthy Adults for Improvement in Immunity Hair Fall Skin Allergies and Pigmentation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT-NUTR/IMM/NCT/I/SEP/2025_Version_1.0_26 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser Cosmetic Surgery Center, |
| Address |
Skinovate Laser Cosmetic Surgery Center Office No 303 Third Floor Royal Avenue
Survey No18 Hissa No.11/6
Next to Hotel Shivar Garden
Pimple Saudagar Rahatani Taluka Haveli Pune
Pune
MAHARASHTRA
411017
India |
| Phone |
09743849130 |
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser Cosmetic Surgery Center, |
| Address |
Skinovate Laser Cosmetic Surgery Center Office No 303 Third Floor Royal Avenue
Survey No18 Hissa No.11/6
Next to Hotel Shivar Garden
Pimple Saudagar Rahatani Taluka Haveli Pune
Pune
MAHARASHTRA
411017
India |
| Phone |
09743849130 |
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Shendkar |
| Designation |
Principal Investigator |
| Affiliation |
Skinovate Laser Cosmetic Surgery Center, |
| Address |
Skinovate Laser Cosmetic Surgery Center Office No 303 Third Floor Royal Avenue
Survey No18 Hissa No.11/6
Next to Hotel Shivar Garden
Pimple Saudagar Rahatani Taluka Haveli Pune
Pune
MAHARASHTRA
411017
India |
| Phone |
09743849130 |
| Fax |
|
| Email |
drsonal.skinovate@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Skinovate Laser Cosmetic Surgery Center |
| Address |
Skinovate Laser Cosmetic Surgery Center Office No 303 Third Floor Royal Avenue Survey No18 Hissa No 11 6 Next to Hotel Shivar Garden Pimple Saudagar Rahatani Taluka Haveli Pune 411017 MAHARASHTRA
411017
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sonal Shendka |
Skinovate Laser Cosmetic Surgery Center |
Skinovate Laser Cosmetic Surgery Center Office No 303 Third Floor Royal Avenue
Survey No18 Hissa No.11/6
Next to Hotel Shivar Garden
Pimple Saudagar Rahatani Taluka Haveli Pune
Pune
MAHARASHTRA |
7385126865
drsonal.skinovate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifepoint Research- Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair Fall Skin Allergies and Pigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blueberry immunity booster |
Placebo (Sugar pill)
Under details, please mention the dose - Single Dose
frequency route of administration - once a day oral
Total duration of such intervention- 8 Weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1 Healthy males and females aged 18–60
2 Mild hair fall pigmentation issues or skin allergy history
3 Willingness to comply and provide informed consent
|
|
| ExclusionCriteria |
| Details |
1 Allergy to study product components
2 Active dermatological systemic disease
3 Pregnant lactating women
4 Recent participation in clinical trials 30 days
5 Use of other hair skin or immunity supplements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate efficacy of Blueberry immunity booster in reducing hair fall compared to placebo after 8 weeks of supplementation. |
Eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Evaluate improvements in skin allergy symptoms itching redness rashes
2 Assess changes in skin pigmentation using objective and subjective measures
3 Evaluate safety and tolerability of Blueberry immunity booster
|
Eight weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Nutraceuticals are dietary supplements designed to provide bioactive compounds that support health beyond basic nutrition. They may have immunomodulatory, antioxidant, and anti-inflammatory properties. The proposed study focuses on a nutraceutical formulated to improve immunity, reduce hair fall, prevent skin allergies, and improve skin pigmentation. |