| CTRI Number |
CTRI/2026/03/106176 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF BIBHITAK TAIL NASYA AND GAMBHARI CHURNA IN HAIRFALL(KHALITYA) |
|
Scientific Title of Study
|
A Pharmaco-Clinical Study To Evaluate The Respective & Cumulative Efficacy Of Bibhitak Tail Nasya And Gambhari Churna In The Management Of Khalitya W.S.R To Hairfall. |
| 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 Anjali khadiya |
| Designation |
M.D. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College Udaipur Rajasthan |
| Address |
P.G. Department Of Dravyaguna Vigyan Vibhag Madan Mohan Malviya Govt.Ayurveda College Ambamata Udaipur Rajasthan, India
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7742138970 |
| Fax |
|
| Email |
anjalikhadiya23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Chandra Mishra |
| Designation |
Associate Professor Of Dravyaguna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College Udaipur Rajasthan |
| Address |
Madan Mohan Malviya Govt.Ayurveda College Ambamata Udaipur Rajasthan, India
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460012476 |
| Fax |
|
| Email |
m.raj3011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali khadiya |
| Designation |
M.D. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College Udaipur Rajasthan |
| Address |
P.G. Department Of Dravyaguna Vigyan Vibhag Madan Mohan Malviya Govt.Ayurveda College Ambamata Udaipur Rajasthan, India
Udaipur
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7742138970 |
| Fax |
|
| Email |
anjalikhadiya23@gmail.com |
|
|
Source of Monetary or Material Support
|
| From MMM College Pharmacy. If Not Available From MMM Pharmacy Then From Market |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt. Ayurved College |
| Address |
Madan Mohan Malviya Govt. Ayurved College
Rada ji Circle Ambamata Udaipur Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Anjali Khadiya |
Attached Hospital Of Madan Mohan Malviya Govt. Ayurveda College Udaipur 313001 Rajasthan |
Attached Hospital Of Madan Mohan Malviya Govt.Ayurveda College OPD No 24 Udaipur 313001 Rajasthan
Udaipur
RAJASTHAN |
7742138970
anjalikhadiya23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Madan Mohan Malviya Govt. Ayurved College Udaipur |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bibhitak tail, Reference: Ashtang Hruday 5/60, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Second Bhaishajya kaal- 1 drop at night before sleep | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gambhari churna, Reference: Bhavprakash Nighantu Guduchyadi varga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bibhitak tail, Reference: Ashtang Hruday 5/60, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Gambhari Churna Orally 2 gm BD With Milk Abhakta Kala Reference-Bhavprakash Nighantu Guduchyadi Varga |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects Age between 18-40 years, irrespective of gender.
2. Subjects presenting with complaints of hair fall and hair damage for at least 3 months.
3. Subjects who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects below the Age of 18 years and above 40 years.
2. Subjects presenting with active scalp infections or dermatological conditions of the scalp.
3. Hair falls resulting from chemotherapy, radiotherapy, recent major surgery or other medically induced causes.
4. Pregnant women.
5. Subjects diagnosed with systemic disorders such as hypothyroidism, hyperthyroidism, polycystic ovarian disease (PCOD), diabetes mellitus, anaemia, autoimmune diseases etc.
6. Subjects unwilling to avoid the use of hair dyes, henna, or any hair treatment procedures during the study period.
7. Congenital & Hereditary.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Clinical manifestation of Khalitya |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the objective parameters of Khalitya and improvement in Quality of Life of patients. |
20 Days, 40 Days, 60 Days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
06/05/2026 |
| 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="11"
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
|
This study is a comparative PHARMACO-CLINICAL STUDY TO EVALUATE THE RESPECTIVE & CUMULATIVE EFFICACY OF BIBHITAK TAIL NASYA AND GAMBHARI CHURNA IN THE MANAGEMENT OF KHALITYA W.S.R TO HAIRFALL. There will be three groups in the study
Group - A
• Dose: Bibhitak (Terminalia bellirica Roxb.) tail nasya /1 drop BD • Duration: Two months • Route of administration: Nasal
Group - B
Dose- Gambhari (Gmelina arborea Linn.) churna/2 gm BD Duration - Two months Route of administration: Oral
Group - C Dose- Bibhitak (Terminalia bellirica Roxb.) tail nasya /1 drop BD Gambhari (Gmelina arborea Linn.) churna/2 gm BD
Duration - Two months
Route of administration: Nasal and Oral
Duration: 2 Months (60 Days)
Follow-Up: Follow-up will be done after 20 Days.
before treatment and after completion of trial, complete history will be recorded. The data will be analyzed scientifically and statistically |