| CTRI Number |
CTRI/2012/02/002461 [Registered on: 28/02/2012] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to evaluate the safety and efficacy of HAIRAL 7 in hair regrowth and in the treatment of dandruff and hair loss in female and male patients.
|
|
Scientific Title of Study
|
A prospective open labeled clinical trial to evaluate the efficacy and safety of “HAIRAL 7†in hair regrowth and in the treatment of dandruff and hair loss in female and male patients.
|
| Trial Acronym |
HAIRAL 7 study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivas C |
| Designation |
Consultant Dermatologist |
| Affiliation |
MCI No: 37700 |
| Address |
Revive skin and hair clinic
Nanjappa Main Road,
Vidyaranyapura, Bengaluru
Revive skin and hair clinic
2276, 3rd main, 4th cross,
Vijayanagar 2nd stage
Bengaluru.
Bangalore
KARNATAKA
560097
India |
| Phone |
08042195246 |
| Fax |
|
| Email |
drsriniskin@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas C MD |
| Designation |
|
| Affiliation |
|
| Address |
Revive skin and hair clinic
Nanjappa Main Road,
Vidyaranyapura, Bengaluru
Revive skin and hair clinic
2276, 3rd main, 4th cross,
Vijayanagar 2nd stage
Bengaluru.
Bangalore
KARNATAKA
560097
India |
| Phone |
08042195246 |
| Fax |
|
| Email |
drsriniskin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas C MD |
| Designation |
|
| Affiliation |
|
| Address |
Revive skin and hair clinic
Nanjappa Main Road,
Vidyaranyapura, Bengaluru
Revive skin and hair clinic
2276, 3rd main, 4th cross,
Vijayanagar 2nd stage
Bengaluru.
Bangalore
KARNATAKA
560097
India |
| Phone |
08042195246 |
| Fax |
|
| Email |
drsriniskin@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABS LABORATORIES |
| Address |
Plot#31, 9-4-62/30/1/2,
Toli Chowki,
Hyderabad-500008,
Andhra Pradesh, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Srinivas C |
Revive skin & hair clinic |
Nanjappa Main Road, Vidyaranyapura, Bengaluru. 2276, 3rd main, 4th cross, Vijayanagar 2nd stage Bengaluru.
Bangalore
KARNATAKA |
080-42195246
drsriniskin@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| clinicom, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
suffering from mild to moderate hair loss and/or Subjects suffering from mild to moderate dandruff. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HAIRAL7 |
The study drug Approx 5-10 mL will be applied to the hair roots till hair roots wet. Applied once daily preferably in the night. Total duration of drug product administration is about 04 months. |
| Comparator Agent |
none |
no comparator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
 Males and females of age group 18-40 years
 Subjects who are suffering from mild to moderate hair loss and/or Subjects suffering from mild to moderate dandruff.
 Subjects who are willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
 Any dermatological condition of the scalp other than hair loss and /or dandruff.
 Prior use of scalp hair growth treatment (e.g., finasteride, minoxidil) within 6 months
 Any prior hair growth procedures (e.g., hair transplant or laser)
 History of alcohol or drug addiction
 History of skin allergy
 Regular use of medication which might interfere with the results of the study
 Subject had used phytotherapy (e.g., saw palmetto) within eight weeks prior to baseline.
 Any active skin infection in the scalp area or scarring in the target area.
 Photosensitivity to laser light.
 Subjects with psoriasis/seborrheic dermatitis
 Medications with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide), topical estrogen, tamoxifen, anabolic steroids, oral glucocorticoids (or other medications at the discretion of the Investigator.(these are the Medications for hair loss)
 History of thyroid or other medical condition including polycystic ovary syndrome that might influence hair growth and loss, at the discretion of the Investigator.
 Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Efficacy Endpoints:
Change in global photographic assessment for hair growth
Change in the investigator assessment score for Hair count each visit from enrollment onwards after treating with IP
Investigator assessments
Reduction in dandruff score for applicable subjects
Secondary End points:
- Subjective Assessment by patient using diary card evaluation
- Assessment of adverse event
|
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Assessment by patient using diary card evaluation
- Assessment of adverse event
|
4 months |
|
|
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)
|
24/02/2012 |
| Date of Study Completion (India) |
21/09/2012 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective open labeled clinical trial which will evaluate the efficacy and safety of “HAIRAL 7†a natural product in hair regrowth and in the
treatment of dandruff and hair loss in female and male patients. Subjects to enter the study should have hair
loss and/ or dandruff. All Subjects will be treated with HAIRAL 7 for 4 months.
The study drug will be applied to the hair roots daily preferably in the night
for 4 months.The treatment duration of study will be 4 Months
for each subject. this study is sponsored by ABS labs which is present at Hyderabad. The study will recruit 60 subjects within 4 months. |