CLINIAL STUDY OF HERBHAIR OIL ON HAIR GROWTH

Not Applicable

Recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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.
Participants who are clinically diagnosed for diffuse hair, Hair loss, minimum hair growth.

Exclusion Criteria

Pregnant or breastfeeding or planning to become pregnant during the study period.
Known case of Hypersensitivity to Investigational drug content.
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.

Primary Outcome Measures

Name	Time	Method
Hair Growth /Regrowth	0 day, 40th day, 80th day and 120th day
Increase in hair density (by Trichoscope)	0 day, 40th day, 80th day and 120th day
Improvement in Hair Texture	0 day, 40th day, 80th day and 120th day
Preventing Hair Loss	0 day, 40th day, 80th day and 120th day
â€¢Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp	0 day, 40th day, 80th day and 120th day

Secondary Outcome Measures

Name	Time	Method
Subjective: Hair Growth, Dandruff, Itching, Dryness, Stiffness of Hair, Perspiration and Burning Sensation In Scalp	Objective: Serum Ferritin levels

Locations (1): KAHERs Shri B M Kankanawadi Ayurved mahavidyalaya & KLE Ayurveda Hospital Shahpur Belagavi
🇮🇳
Belgaum, KARNATAKA, India
KAHERs Shri B M Kankanawadi Ayurved mahavidyalaya & KLE Ayurveda Hospital Shahpur Belagavi
🇮🇳Belgaum, KARNATAKA, India
Dr Mahadev Gundakalle
Principal investigator
9916885310
mahadevgundakalle@yahoo.com