| CTRI Number |
CTRI/2022/10/046767 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of VISPO in Healthy Adult Male and Female Subjects Suffering with Mild to Moderate Androgenetic Alopecia. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Study to Evaluate the Efficacy and Safety of VISPO in Healthy Adult Male and Female Subjects Suffering with Mild to Moderate Androgenetic Alopecia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Sriram |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
987980038 |
| Fax |
|
| Email |
drrashmiclinicalresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bioservices Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bioservices Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Rashmi Sriram |
BGS Global Institute of Medical Sciences |
Department of Dermatology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
0987980038
drrashmiclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult Male and Female Subjects Suffering with Mild to Moderate Androgenetic Alopecia. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
5ml lotion 5ml lotion once a day for 112 days |
| Comparator Agent |
Placebo |
Oral administration of single dose of Placebo 400mg capsule everyday for 112 days |
| Intervention |
Vispo |
5ml lotion once a day for 112 days |
| Intervention |
Vispo |
Oral administration of single dose of Vispo 400mg capsule everyday for 112 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
l Healthy subjects, as determined by the investigator.
3. Presence of androgenetic alopecia In male: Norwood Hamilton Scale grade II to VA with vertex involvement. In females: Sinclair scale for female pattern hair loss: Grade II to IV.
4. Agrees not to use products with the same end benefit during the entire study period.
5. Willingness to be photographed and provide consent for photographic release.
6. Subjects who agree to refrain from using hair dye / hair colour/ hair treatment (like perming,
straightening etc.) during the study period.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having conditions like alopecia areata, alopecia totalis, alopecia universalis and alopecia
diffusa.
2. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
3. Subjects with history of any chronic health conditions, Endocrine abnormalities, Pychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Bariatric surgery/ eating disorder such as bulimia or binge eating. History of any other major surgery
4. Use of the following during the 6 months prior to screening:
Minoxidil (oral or topical)
Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketocnazole,
flutamide, bicalutamide).
Cimetidine cannot be used during the study but is not an excluded drug when used during the previous
6 months.
Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens),
Anabolic steroids, Lithium and phenothiazines.
Use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the study. Use of isotretinoin, light therapy, radiation to the scalp, or chemotherapy within the past year.
5. Subjects allergic to herbal products or any component of the study product
6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
7. Subjects who have had hair transplant.
8. Subjects on any medical treatment either systemic or topical which may interfere with the performance
of the study treatment (presently or in the past 1 month).
9. Menopausal female subjects as determined by medical history
10.Known HIV or Hepatitis B positive or any other immuno-compromised state
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hair fall |
Day 1, Day 56 and Day 112 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Hair density and Questionnaire based assessments |
Day 1, Day 56 and Day 112 |
| Mean change in Biomarkers |
Day 1,Day 112 |
| Over all Safety |
Day 1, Day 56 and Day 112 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
27/10/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double blind, randomized (1:1:1:1), placebo controlled, parallel group, four arm study. Adult healthy subjects suffering from mild to moderate androgenetic alopecia (AGA) and meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. The subject will arrive at the study site in fasting state and blood samples will be collected for laboratory assessment. The subjects will visit their designated study site on 3 different occasions during the 12-week study duration.
|