| CTRI Number |
CTRI/2026/03/107036 [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 Collagen on Skin Health in Healthy Adults |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Subject-Based Clinical Study to Evaluate the Efficacy of Liposomal Collagen (LipoLushTM) Supplementation on Skin Health 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin health in healthy adults, including hydration, elasticity, firmness, and reduction of wrinkles and fine lines. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Liposomal Collagen (LipoLushTM) |
Dose: 7 g
Each sachet contain 5 g of liposomal collagen (LipoLush™) will be reconstituted in 150–200 mL of water and consumed orally once daily after a meal, preferably at the same time each day.
Duration: 56 days
|
| Comparator Agent |
Non-Liposomal Collagen (PeptiGlow™) |
Dose: 7 g
Each sachet contain 5 g of non-liposomal collagen (PeptiGlow™) will be reconstituted in 150–200 mL of water and consumed orally once daily after a meal, preferably at the same time each day.
Duration: 56 days
|
| Comparator Agent |
Placebo |
Dose: 7 g
Each sachet contain 0 g of active collagen will be reconstituted in 150–200 mL of water and consumed orally once daily after a meal, preferably at the same time each day.
Duration: 56 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adults aged equal to or more than 18 years.
2.In good general health based on medical history.
3.Visible crow’s feet wrinkles (grade equal to or greater than 2).
4.Willing to avoid other collagen or skin-related supplements during the study.
5.Willing to use only the skincare products provided in the study.
6.Able and willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.Recent facial dermatologic procedures (laser, chemical peel, fillers, botulinum toxin).
3.Active facial skin disorders.
4.Known allergy or hypersensitivity to collagen.
5.Participation in another clinical trial within the past 30 days.
6.Vegan or vegetarian diet restricting animal-derived collagen.
|
|
|
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 |
1. Skin elasticity measured using a Cutometer.
2. Crow’s feet wrinkle count assessed by blinded dermatologist using standardized facial photography (with optional ImageJ analysis).
|
Baseline, Week 4 and Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wrinkle depth and area assessed by blinded dermatologist with standardized photography (optional ImageJ analysis).
|
Baseline, Week 4 and Week 8 |
| Skin hydration measured using a Corneometer. |
Baseline, Week 4 and Week 8 |
| Skin colour parameters (pigmentation and erythema) measured using a Mexameter. |
Baseline, Week 4 and Week 8 |
| Subjective skin improvement assessed using a self-reported questionnaire. |
Baseline, Week 4 and Week 8 |
| Plasma collagen-derived peptides measured by validated LC–MS. |
Baseline and Week 8 |
| Serum P1NP levels measured by ELISA as a marker of collagen synthesis. |
Baseline and Week 8 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2026 |
| Date of Study Completion (India) |
18/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Skin ageing and reduction in skin
elasticity are common concerns among adults and may affect overall skin
appearance and quality of life. With increasing age, collagen levels in the
skin gradually decline, leading to wrinkles, reduced firmness, and loss of
elasticity. Oral collagen supplementation is widely used to support skin
structure and improve skin health; however, conventional collagen
formulations may have limited absorption.
Liposomal collagen (LipoLush™) is
a novel formulation designed to enhance oral absorption and bioavailability
of collagen peptides. This randomized, double-blind, placebo-controlled
clinical study aims to evaluate the efficacy and safety of liposomal collagen
supplementation compared with placebo in healthy adults.
The study will assess changes in
skin elasticity, wrinkle parameters (including wrinkle count, depth, and
area), skin hydration, and overall skin appearance. Exploratory assessments
will include biochemical markers related to collagen metabolism. Safety will
be evaluated through monitoring of adverse events. The study is intended to
generate clinical evidence supporting the effectiveness of liposomal collagen
supplementation in improving skin health and reducing visible signs of skin
ageing in healthy adults.
|
|