A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Keshkusum An Oil based Scalp Serum As Keshya Therapy In Reducing Khalitya (Excessive Hair Fall) Among Healthy Individuals.

Title

A Randomized Comparative Clinical Study To Evaluate The Efficacy Of **“**Keshkusum” -An Oil based Scalp SerumAs KeshyaTherapy in Reducing Khalitya (Excessive Hair Fall) Among Healthy Individuals.

  |PG Scholar

Dr. Trisha S. Suvarna

|Guide

Dr. Pratik Patil

|Study site

Padmashree Dr D Y Patil Deemed to be University, School of Ayurveda,

Nerul, Navi Mumbai-400706.

|Study Design

Randomised, open labelled, double arm , comparative prospective clinical study.

|Study duration

60 days

|Aim

To evaluate the clinical efficacy of  “Keshkusum” -An Oil based Scalp Serum as a topical Keshya therapy in reducing Khalitya (Excessive Hair fall) among healthy individuals .

  |Objectives

1. To develop and standardize **“**Keshkusum” -An Oil based Scalp Serum
2. To evaluate the changes in reduction of hair fall.
3. To provide clinical evidences on how classical Ayurvedic herbs and practices can be reformulated into  modern, user-friendly formats like serums.
4. To assess patient satisfaction and compliance of the oil-based serum.

   |Population to be studied

Healthy individuals with hair fall will be screened from Swasthya rakshanOPD No-6, Kayachikitsa OPD No-1 and Screening Camps conducted by Padmashree D.Y Patil University School of Ayurveda, Nerul, Navi Mumbai.

|Sample size

GROUP A -35 participants (considering 20% dropout rate)

GROUP B -35 participants (considering 20% dropout rate)

  |Inclusion criteria

     1.     Individuals aged 18 to 45 years .

2.     Both males and females with self-reported excessive hair fall (with the females having  40-50 counts of hair fall and male having 25-30 counts of hair fall) as determined from 60 second hair combing method at screening visit.

3.     Good general health with no diagnosed systemic or dermatological illness.

4.     Willingness to provide informed written consent and comply with study protocol.

   |Exclusion criteria

1.Pregnant women and Lactating mothers.

2.Any systemic illness (e.g., thyroid dysfunction, anemia , PCOS) and treatments (e.g. chemotherapy) that could cause secondary hair fall.

3. Use of topical or oral hair loss treatments in the last 3 months

4.Individuals with diagnosed alopecia areata, androgenic alopecia, or scalp infections

|Efficacy parameters

1.     Khalitya signs and symptoms by  VAS Scale

2.     Hair Pull test.

3.     60 second Hair comb test

4.     Dermatoscope

5.     HairDex Quality of Life Questionnaire

|Safety parameters

Adverse events recording.

|Efficacy & Safety parameters Assessment Schedule

1.     Khalitya signs and symptoms by  VAS Scale- V1,V2,V3,V4.V5

2.     Hair Pull test- V1,V2,V3,V4,V5

3.     60 second Hair comb test- V1,V2,V3,V4,V5

4.     Dermatoscope- V1,V5

5.     Physical examination: will be done on V1, V2, V3, V4, V5

6.     HairDex Quality of Life Questionnaire V1 and V5

7.     Questionnaire after completion of treatment-V5

|Statistical Analysis

Inter-Group Comparison:

Mann-Whitney U test (for non-parametric data), Unpaired t test (parametric data)

 

S.NO.

GROUPS

GROUP A

GROUP B

|1.

PROCEDURE

Keshkusum -An Oil Based Scalp Serum + Bhringaraj Ghanavati

Bhringraj  Ghanavati

|2.

ROUTE

Oral +Topical

Oral

|3.

DOSAGE

Keshkusum - Q.S

*Bhringraj Ghanavati -*1 tablet (250 mg) thrice daily

*Bhringraj Ghanavati -*1 tablet (250 mg) thrice daily

|4.

TIME OF ADMINISTRATION

Keshkusum – once at night in sufficient quantity.

Bhringraj  Ghanavati-Morning, Afternoon and Night after food.

*Bhringraj  Ghanavati –*Morning, Afternoon and Nightafter food.

|5.

DURATION

60 days

60 days

|6.

NO. OF PARTICIPANTS

30

30

|7.

VISITS/ FOLLOW UP

15th day ,

30th day,

45th day,

60th day

15th day ,

30th day,

45th day,

60th day