| CTRI Number |
CTRI/2019/12/022497 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
07/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Hair Oil External Application] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINIAL STUDY OF HERBHAIR OIL ON HAIR GROWTH |
|
Scientific Title of Study
|
Evaluation of HERBHAIR OIL to improve Hair Growth - A Pre-Post Assessment Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Giridhar Vedatnam |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi |
| Address |
KAHERs Shr B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
BELAGAVI
Karnataka
590003 India
Belgaum
KARNATAKA
59003
India |
| Phone |
9731028625 |
| Fax |
|
| Email |
drgiridharay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Giridhar Vedatnam |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi |
| Address |
KAHERs Shr B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
BELAGAVI
Karnataka
590003 India
Belgaum
KARNATAKA
59003
India |
| Phone |
9731028625 |
| Fax |
|
| Email |
drgiridharay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giridhar Vedatnam |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi |
| Address |
KAHERs Shr B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
BELAGAVI
Karnataka
590003 India
Belgaum
KARNATAKA
59003
India |
| Phone |
9731028625 |
| Fax |
|
| Email |
drgiridharay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhayalaxmi Industries
51 EC exon, Kushaiguda
KAPRA MEDCHAL - MALKAJGIRI, State Telangana |
|
|
Primary Sponsor
|
| Name |
Bhagyalaxmi Industries Hyderabad |
| Address |
Bhayalaxmi Industries
51 EC exon, Kushaiguda
KAPRA MEDCHAL - MALKAJGIRI, State Telangana |
| 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 Mahadev Gundakalle |
KAHERs Shri B M Kankanawadi Ayurved mahavidyalaya & KLE Ayurveda Hospital Shahpur Belagavi |
OPD - NIRVISHA (SKIN OPD)
Belgaum
KARNATAKA |
9916885310
mahadevgundakalle@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KAHERS Shr B M Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital, Shahapur, Belagavi |
Approved |
| Institutional Ethics Committee, KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital, Shahapur, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair Loss, Diffuse Hair, low dense hair |
| Patients |
(1) ICD-10 Condition: L63||Alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HERBHAIR OIL |
Herbhair oil (quantity sufficient) will be applied externally on scalp once daily for 120 days |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female participants, whose age is more than 18 years;
2. Participants who are willing to give written, signed and dated informed consent to participate in the study.
3. Participants who are clinically diagnosed for diffuse hair, Hair loss, minimum hair growth
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding or planning to become pregnant during the study period.
2. Known case of Hypersensitivity to Investigational drug content.
3. Patient using any other treatment for this indication at the same time
4. Received any other investigational medicinal therapy within 30 days and topical therapy within 7 days prior to screening
5. Patient suffering from any active general illness or have History of any general illness
6. Patient on chemotherapy/ Radiotherapy/Tuberculosis
7. K/C/O of Diabetes, Immuno compromised condition Like HIV I and II, HbsAg
8. Any condition or disease which is considered unfit for study and which may interfere with study therapy as decided by clinical investigator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hair Growth /Regrowth
Increase in hair density (by Trichoscope)
Improvement in Hair Texture
Preventing Hair Loss
• Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp |
0 day, 40th day, 80th day and 120th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective: Hair Growth, Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp
Objective: Serum Ferritin levels |
Subjective: 1, 40, 80 and 120 days
Objective: Serum Ferritin, CBC - 0 and 120 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/12/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Proposed Study is Single Centric Single Arm Clinical Trial with Pre-Post Assessment Design on HERBHAIR OIL external application on scalp once daily for 120 days in Healthy volunteers complaining of Hair loss, Low Density of Hair or Diffuse Hair. Study is post market study for generating more clinical data on already licensed Ayurveda Proprietary Preparation to promote hair growth. It does not guarantee miraculous effect on hair and based on classical Ayurvedic drugs for hair growth. Study will be on 50 heathy volunteers who will give consent to participate. Initial skin patch test will be done with external application hair prior to inclusion in study to prevent inclusion of subject allergic to the test product. |