| CTRI Number |
CTRI/2026/01/102170 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Assess a Herbal Formulation for Hair Fall |
|
Scientific Title of Study
|
Evaluation of Efficacy of Polyherbal Formulation in Hair Fall (Khalitya) A Randomized Controlled Trial |
| 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 Payal Premsing Ade |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Address |
OPD no 5, Kayachikitsa Department ,Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8999239712 |
| Fax |
|
| Email |
payalade26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digambar Ganpati Dipankar |
| Designation |
HOD Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD no. 5, Kayachikitsa Department,Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Premsing Ade |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD no. 5, Kayachikitsa Department,Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8999239712 |
| Fax |
|
| Email |
payalade26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Payal Premsing Ade |
| Address |
Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
| 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 Payal Premsing Ade |
Dr. D. Y. Patil College of Ayurved and Research Centre |
OPD No. 5, Kayachikitsa Department,Dr D Y Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune,411018
Pune
MAHARASHTRA |
8999239712
payalade26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.DYPCA and RC Institutional Ethics Committee Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Polyherbal Formulation, Reference: 1. Gambhari Bhavaprakasha Nighantu, Guduchyadi Varga 2. Nirgundi Bhavaprakasha Nighantu, Guduchyadi Varga 3. Neeli Bhavaprakasha Nighantu, Guduchyadi Varga 4. Bhringaraja Bhavaprakasha Nighantu, Guduchyadi Varga 5. Japa Pushpa Bhavaprakasha Nighantu, Pushpa Varga 6. Bijaka Bhavaprakasha Nighantu, Vatadi Varga 7. Bibhitaki Bhavaprakasha Nighantu, Haritakyadi Varga 8. Yashtimadhu Bhavaprakasha Nighantu, Haritakyadi Varga 9. Gokshura Sharangadhara Samhita 10. Krishna Tila Base oil Bhavaprakasha Nighantu, Dhanya Varga, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Neelibhringadi oil, Reference: Neelibhringadi Taila as per Sahasrayoga., Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients within age group 18-45 years.
Patients diagnosed with Hair Fall (Keshapatan) Roughness (Kesharukshata). |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating womens.
Patients having hereditary history of baldness, having hair loss due to injury, suffering from severe systemic disease.
Patient who has undergone chemotherapy.
Patients with dermatological disorders like psoriasis, Alopecia areata, Alopecia totalis, Tinea capitis, Eolliculitis decalvans. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Hair Fall (Keshapatan) according to their gradation.
Reduction in Dryness of hair (Kesharukshata) according to their gradation. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hair Comb Test, Hair Pull Test. |
28 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/02/2026 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized comparative clinical study aims to evaluate the efficacy of a Polyherbal Formulated oil in comparison with Neelibhringadi oil in the management of Hair Fall (Khalitya). A total of 50 patients aged between 18 and 45 years diagnosed with Khalitya will be randomly allocated into two groups of 25 patients each. Group A will receive Polyherbal Formulated oil and Group B will receive Neelibhringadi oil for topical application on the scalp once daily at night for 28 days.
Assessment will be carried out on the 14th and 28th day using subjective parameters such as hair fall (Keshapatan) and hair roughness (Kesharukshata), along with objective parameters including hair pull test, hair comb test. Statistical analysis will be done to compare the effectiveness of both interventions.
The study is expected to provide evidence regarding the effectiveness of the Polyherbal Formulation in reducing hair fall and improving scalp health. |