| CTRI Number |
CTRI/2026/01/100367 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of an Oil based Scalp Serum in the Management of Khalitya (Excessive Hair Fall) |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trisha Surendra Suvarna |
| Designation |
PG Scholar (Swasthavritta) |
| Affiliation |
Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda. |
| Address |
DY Patil Ayurvedic Hospital, 1st floor, Swasthyarakshan OPD No-6 and Kayachikitsa OPD No-1, Sector 7, Nerul east, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8454809009 |
| Fax |
|
| Email |
tri.suv.bams24@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Patil |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda. |
| Address |
Padmashree Dr DY Patil Deemed to be University, School Of Ayurveda, Sector 7, Nerul east, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9762224740 |
| Fax |
|
| Email |
pratik.patil@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trisha Surendra Suvarna |
| Designation |
PG Scholar (Swasthvritta) |
| Affiliation |
Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda. |
| Address |
Padmashree Dr DY Patil Deemed to be University,School of Ayurveda, Sector 7, Nerul east, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8454809009 |
| Fax |
|
| Email |
tri.suv.bams24@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai, Maharashtra- 400706 India |
|
|
Primary Sponsor
|
| Name |
Dr Trisha Surendra Suvarna |
| Address |
Padmashree Dr DY Patil Deemed to be University, School Of Ayurveda, 1st floor- Swasthyarakshan OPD No-6 and OPD No-1 (Kayachikitsa) Sector-7, Nerul east, Navi Mumbai, Maharashtra- 400706 India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Trisha Surendra Suvarna |
DY Patil Ayurvedic Hospital |
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, 1st floor, Swasthyarakshan OPD No-6 and Kayachikitsa OPD No-1, Sector 7, Nerul east, Navi Mumbai, Maharashtra- 400706 India.
Thane
MAHARASHTRA |
8454809009
tri.suv.bams24@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DY Patil Deemed to be University, School of Ayurveda. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Keshkusum, Reference: Bhavaprakash, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Keshkusum- An Oil based Scalp Serum is advised in sufficient quantity | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhringraj Ghanavati, Reference: Ayurvedic Pharmacopoeia of India , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce hair fall, dandruff, roughness of hair surface, itching of hair scalp, dryness of hair |
15th day,30th day, 45th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title | 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. | 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 | - To develop and standardize “Keshkusum” -An Oil based Scalp Serum
- To evaluate the changes in reduction of hair fall.
- To provide clinical evidences on how classical Ayurvedic herbs and practices can be reformulated into modern, user-friendly formats like serums.
- 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 rakshan OPD 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 Night after 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 |
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