Study of Hair mist on hair repigmentation

Phase 2

Not yet recruiting

Brief Summary: The purpose of this study is to check ability of prepared herbal formulation in change in hair color of â€˜grey hairâ€™ by photographic and questions based response of subject. Formulation application is topical. No any systemic investigation. Based on above assumption and considering the 20% dropout rate, we proposed to enroll 72 subjects as 36 in each group to get 60 cases (each group 30) at the end of study.

Further each group will be divided in two sub groups based on the age as 20-40 and 41-60 years.

Henceforth final groups for the study;

| | | | |

| --- | --- | --- | --- |

|**Group**

**Age**

**Treatment**

**No. of subjects**

|I

20-40

Formulation

18

|II

41-60

Formulation

18

|III

20-40

Placebo

18

|IV

41-60

Placebo

18

Frequency of application: twice in a day

Recruitment & Eligibility

Inclusion Criteria

Presence of gray hairs Person willing to sign an informed consent Person ready to stop application of any hair color or dye 15 days prior to treatment and throughout the treatment.
Person with normal hemoglobin count Either male or female.

Exclusion Criteria

Person suffering from any life-threatening disease/disorder.
Person not willing to come for follow-up when required.
Person who is part of any other clinical trial.
Person having any allergy to included ingredients.
Other conditions which in opinion of the investigator make subject unsuitable for study.
Female with pregnancy.

Primary Outcome Measures

Name	Time	Method
Change in hair color from white to original color.	90 days
Safety assessment	90 days

Secondary Outcome Measures

Name	Time	Method
Stimulation of hair growth	90 days

Locations (1): Arogyashala Rugnalaya, Ganeshwadi , Nashik.
🇮🇳
Nashik, MAHARASHTRA, India
Arogyashala Rugnalaya, Ganeshwadi , Nashik.
🇮🇳Nashik, MAHARASHTRA, India
Dr Sheetal Chavan
Principal investigator
9272642873
dr.sheetalyadav59@gmail.com