| CTRI Number |
CTRI/2024/07/071054 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on NR-INF-IB on skin in healthy participants |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of NR-INF-IB on skin in healthy
participants - A randomized, double-blind, placebo controlled,
prospective clinical study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NRPL/SK/NR-INF-IB/2024/CT-1, Version 1.0, 06 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaam Agarwal |
| Designation |
Consultant Dermatologist |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd. |
| Address |
Department of Clinical Study, 2ndfloor, OPD 1,
Target Institute of Medical Education and Research Pvt Ltd. E 203, Jaymala Business Court, Takle Nagar Manjri BK. Hadapsar Pune
Pune
MAHARASHTRA
412307
India |
| Phone |
9422026123 |
| Fax |
|
| Email |
drshaam@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,A Wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,A Wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Pvt Ltd
Plot No. 5B, Veerasandra Industrial Area,
19th K.M. Stone, Hosur Road Post,
Phase 2, Electronic City, Bengaluru, Karnataka 560100 |
|
|
Primary Sponsor
|
| Name |
Natural Remedies Pvt Ltd |
| Address |
Plot No. 5B, Veerasandra Industrial Area,
19th K.M. Stone, Hosur Road Post,
Phase 2, Electronic City, Bengaluru, Karnataka 560100
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
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 Shaam 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 |
9422026123
drshaam@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mhaske Hospital and Research Centre, Hadapsar, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NR-INF-IB-01@250 mg Capsules |
Subjects will receive 2 capsules once daily for 8 weeks |
| Comparator Agent |
NR-INF-IB-02@1000 mg Capsules |
Subjects will receive 2 capsules once daily for 8 weeks |
| Comparator Agent |
NR-INF-IB-02@500 mg Capsules |
Subjects will receive 2 capsules once daily for 8 weeks |
| Comparator Agent |
Placebo Capsules |
Subjects will receive 2 capsules once daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female participants (Healthy individuals will be defined as who do not require any continuous or urgent medical or surgical treatment for any systemic disease. Also with respect to skin, healthy skin will be defined as those without any skin blemishes of infective or non infective pathology like acne, hyper pigmentation or hypopigmentation etc.)
2. Willing to provide informed consent and comply with all requirements of the study protocol including follow up visits
|
|
| ExclusionCriteria |
| Details |
1.Participants with non intact skin surface for instrumental assessment (wounds, moles etc.)
2. Pregnant or nursing woman or planning a pregnancy during the study.
3. Participants with a skin tattoo, scar(s), mole(s), excessive hairs or any
condition of the skin surface, which might interfere with the evaluation.
4. Participants who have been exposed to excessive sunlight or UV-rays within the previous month and are anticipated to be exposed during the study period.
5. Participants diagnosed with or having a history of hypertension, hyper or hypothyroidism
6. Participants diagnosed with anemia or are known cases of diabetes.
7. Participants suffering from any severe or progressive systemic or local disease or any other pathology that may interfere with the evaluation of the study results.
8. Participants with known history of or suffering from autoimmune disease and/or immune deficiency.
9. Participants suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma)
10. Participants having received laser treatment or derma abrasion, surgery, deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 1 month prior to the study
11. Participants having received resorbable filling product (injection) in the cheeks or the neckline area within the past 18 months prior to the study
12. Participants undergoing topical treatment on the test area or a systemic treatment including anti-histamines for the past 2 weeks prior to study; immunosuppressive and or corticoids for the last 4 weeks prior to study; retinoid for the 6 months prior to the study.
13. Known hypersensitivity to any of the ingredients of test products
14. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his or her participation in the stud
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in water content hydration of the skin surface assessed using Corneometer
2. Change in Trans epidermal water loss (TEWL) assessed using Tewameter
|
Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in skin elasticity assessed using Cutometer
2. Change in skin softness and smoothness on graded scale
3. Change in Investigators Global Assessment on Likert 5 points scale
4. Assessment of adverse events adverse drug reactions including vitals
|
Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
It is a randomized, double-blind,
placebo controlled, prospective clinical study to evaluate efficacy and safety
of NR-INF-IB on skin in healthy participants. The study will be carried out in
one centre in India. As per computer generated randomization list, subjects
will be randomized to one of the four groups (NR-INF-IB-01@250 mg Capsules, NR-INF-IB-02@500
mg Capsules, NR-INF-IB-02@1000 mg Capsules or Placebo capsules) in 1:1:1:1
ratio. Subjects will be asked to consume given product in a dose of 2 capsules
once daily for 8 weeks. The primary objectives of the study will be to assess change
in water content hydration of the skin surface assessed using Corneometer and change
in Trans epidermal water loss (TEWL) assessed using Tewameter. Secondary objectives
will be to assess change in skin elasticity assessed using Cutometer, change in
skin softness and smoothness on graded scale, change in Investigator’s Global
Assessment on Likert 5 points scale and adverse events adverse drug reactions including
vitals 0n screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week
4) and Visit 2 (Week 8) |