| CTRI Number |
CTRI/2024/06/069335 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the safety and efficacy of test products in healthy adult human subjects having complains of hair fall and premature grey hair. |
|
Scientific Title of Study
|
Scientific evaluation of the safety and efficacy of herbal and non-herbal formulations in mitigating hair fall, promoting hair growth, and preventing premature hair graying. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230043-NB, 1.0, 03Jun24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maheshvari Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
|
Source of Monetary or Material Support
|
| NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
|
|
|
Primary Sponsor
|
| Name |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421,
Gujarat – India
|
| Type of Sponsor |
Contract research organization |
|
|
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 Maheshvari Tamboli Patel |
NovoBliss Research Pvt. Limited |
Clinical Trail Department.
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT |
9909013286
maheshvari@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 |
| Healthy Human Volunteers |
Healthy Human Volunteers having hair fall and premature Hair Greying. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test Product A: Poly herbal Based Hair Oil
|
Apply oil with the help of fingertips on your scalp and massage it gently enabling it to penetrate into the roots (follicle) of your hair. Dont apply with your palms and never rub it vigorously as it may uproot weak hair. Let the oil gradually seep into follicle of your hair & nourish them for the whole night. The oil may be removed in the morning by washing of hair with Ayurvedic Shampoo.
Frequency- Three times a week.
Route of Administration- Topical
Total Duration: 120 Days |
| Comparator Agent |
Test Product B: Poly herbal Based Hair Oil + Minoxidil Serum |
Mode of usage: First, apply the herbal hair oil generously to your scalp and hair, ensuring thorough coverage. Gently massage it in with your fingertips to promote circulation and absorption. After the oil application, follow the instructions provided for the application of the hair serum. Apply the serum to the areas of your scalp where you desire hair growth, using the dropper provided or as directed. Massage it gently into your scalp to ensure even distribution and absorption. Leave the serum on without rinsing. Frequency- For serum- Night application For Oil - Three times a week Route of Administration- Topical. Dose: For oil - Required amount For serum - prescribed amount Dosage Form: Liquid
Total Duration: 120 Days |
| Comparator Agent |
Test Product C: Test Product Name: Minoxidil Hair Serum (5%) |
Apply the amount prescribed to the area of the scalp being treated, beginning in the center of the area. Frequency- Daily night application. Route of Administration- Topical Dose: Prescribed amount Dosage Form: Liquid
Total Duration: 120 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 55 years and above (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4) Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
6) Subject having AGA and premature Gray hair at a time of screening.
7) Subject having premature gray hair at a time of screening.
8) Subject with pro-claimed nonpathological thinning of hair.
9) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
10) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
11) Subjects are willing to give written informed consent and are willing to follow the study procedure.
12) Subjects who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
13) Willing to use test products throughout the study period.
14) Subject is willing and able to follow and allow study staff to performed study test methods.
15) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
16) Subject must be able to understand and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
2) Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
3) Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
4) Subject who had taken topical treatment of hair loss for at least 4 weeks.
5) Subject who had taken any systemic treatment for at least 3 months.
6) History of alcohol or drug addiction.
7) Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8) Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
9) Pregnant or breast feeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state.
11) Subject have participated any clinical research study related to hair care products.
12) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test products in terms of change in
1.hair thickness, hair density and scalp condition, hair strength, scalp skin hydration, ASFS score
2.hair growth rate
3.hair fall
4.A:T ratio
5.GSS score
|
From baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
for pluck test and GSS score - from baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate the effectiveness of the test products in terms of change in general appearance of hair like hair volume, air plasticity, hair density, hair shininess, hair smoothness, hair oiliness from baseline before and after usage of the test products and between the test products. |
from baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by dermatologist and dermatologist trained evaluator and also compare with the between test products. |
| 2.To evaluate the effectiveness of the test products in terms of change in general appearance of scalp like Itchiness, redness, roughness, and scaliness from baseline before and after usage of the test products and between the test products. |
from baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by dermatologist or dermatologist trained evaluator and also compare with the between test products. |
| 3.To evaluate the effectiveness of the test products in terms of change in digital photographs of the head crown from baseline before and after usage of the test products and between the test products. |
from before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by using Nikon digital camera D3300 and also compare the between test products and also compare with the between test products. |
| 4.To evaluate the effectiveness of the test products in terms of product perception questionnaire from the baseline before and after usage of the test products and between the test products. |
before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120 by using 5-point Likert scale and also compare with the between test products |
| To evaluation effect of the test product in terms of change in hair sensorial parameter at different time points through the 6-expert panel. |
Before and after usage of test products on Day 01. |
| To evaluate the effectiveness of the test products in terms of change in shine of the hair after usage of the test products at different time points. |
Before and after usage of test products on Day 01. |
| To evaluate the effectiveness of the test products in terms of change in damage repair from baseline before and after usage of the test products and between the test products. |
Before and after usage of test products on Day 01. |
| To evaluate the effectiveness of the test products in terms of change in lipid deposition through the XRF method. |
Before and after usage of test products on Day 01. |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
28/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Scientific Evaluation of the Safety and Efficacy of Herbal and Non-Herbal Formulations in Mitigating Hair Fall, Promoting Hair Growth, and Preventing Premature Hair Greying. A sufficient number of 78 subjects will be enrolled to 75 complete the study. There are total 6 visits in the study. - Visit 01: Screening, Tattoo creation, Hair Growth Rate measurement - Visit 02: Enrolment, Hair Growth Rate measurement, All evaluations - Visit 03: Treatment Phase - Visit 04: Treatment Phase, Tattoo creation, Hair Growth Rate measurement - Visit 05: Hair Growth Rate measurement, All evaluations - Visit 06: End of Treatment Phase, All evaluations
|