| CTRI Number |
CTRI/2025/11/096865 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate efficacy of brihatyadi taila nasya in Baldness. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate efficacy of brihatyadi taila nasya madhukadi taila nasya in management of khalitya with special reference to baldness Androgenic alopecia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita Hilal Shirsath |
| Designation |
Pg scholar |
| Affiliation |
R.A. Podar Medical (ayu) College Worli ,Mumbai. |
| Address |
Department OF Panchkarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
India.
Department Of Panchkarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
India.
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9421535788 |
| Fax |
|
| Email |
surajmagar717@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSeema Bahatkar |
| Designation |
MD PHD HOD And Professor of Panchakarma |
| Affiliation |
R.A. Podar Medical (ayu) College Worli ,Mumbai. |
| Address |
Department OF Panchkarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
Department of Panchkarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
India.
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9881900560 |
| Fax |
|
| Email |
seemabahatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Hilal Shirsath |
| Designation |
Pg scholar |
| Affiliation |
R.A. Podar Medical (ayu) College Worli ,Mumbai. |
| Address |
Department of Panchakarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
epartment of Panchakarma, opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
India.
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9421535788 |
| Fax |
|
| Email |
surajmagar717@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Hospital Worli Mumbai Maharashtra.400018 |
|
|
Primary Sponsor
|
| Name |
R.A.Podar medical (ayu) college worli mumbai 18 |
| Address |
Panchkarma opd no7 MA Podar Hospital Worli,Mumbai Maharashtra 400018
India. |
| 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 Kavita Hilal Shirsath |
MA Podar Hospital, Worli, Mumbai, 400018 |
R A Podar Medical (Ayu) College, Worli, Mumbai MAHARASHTRA 400018 India
Mumbai
MAHARASHTRA
400018
India
Mumbai
MAHARASHTRA |
9421535788
surajmagar717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of Instituition, R A Podar Medical College (Ayu) Worli, Mumbai, Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L649||Androgenic alopecia, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: (Procedure Reference: Su.Chi.40/58, Procedure details: Patient will be asked to fill mouth sufficient quantity of warm water.The water is hold untill kapha like watery discharge fills the mouth,then spitted.Same procedure will be repeated for 7 days.))
(1) Medicine Name: Koshna jal, Reference: NA, Route: Oral, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ch.su.5/86,Su.Chi.32/13 , Procedure details: patient will be asked to lie in supine position on n the table.Abhyang with lukewarm Tiltail over face and neck region will be done for 5 minutes)
(1) Medicine Name: Til tail, Reference: Ch.Su.13/12, Route: Oral, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Ch.su 14/5, Procedure details: Mrudu Swedana in the form of Tapasweda using cloth soaked in hot water over Face ,neck & forehead for 5 min)
| | 4 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ah.Su.20/10, Procedure details: patient will be made to lie in supine position on the table with head lower than body level[head low position].using dropper Brihatyadi Taila will be dropped 8 drops[one drop will be taken as 0.23ml]in each nostril.Then the patient will be asked to take deep inhalation.)
(1) Medicine Name: Brihatyadi tail, Reference: Ah.U.24/33, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days | | 5 | Intervention Arm | Procedure | - | dhUmapAnam, धूमपानम् | (Procedure Reference: Ah.su21, Procedure details: Patient asked to spit the medicine which reaches the throat and after.patient should sit straight,be attentive and inhale the smoke through each nostril alternatively.smoke should inhaled by nose and exhaled by mouth strictly.This procedure repeated for three times.)
(1) Medicine Name: Dhoomvarti, Reference: Ah.su21, Route: Nasal, Dosage Form: Sprays, Dose: 3(NA), Frequency: od, Duration: 7 Days | | 6 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Su.Chi.40/58, Procedure details: Patient will be asked to fill mouth sufficient quantity of warm water.The water is hold untill kapha like watery discharge fills the mouth,then spitted.Same procedure will be repeated for 7 days.)
(1) Medicine Name: Koshna jal, Reference: NA, Route: Oral, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 7 Days | | 7 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ch.su.5/86,Su.Chi.32/13, Procedure details: patient will be asked to lie in supine position on n the table.Abhyang with lukewarm Tiltail over face and neck region will be done for 5 minutes))
(1) Medicine Name: Til tail, Reference: Ch.Su.13/12, Route: Oral, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 7 Days | | 8 | Comparator Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Ch.su 14/5, Procedure details: Mrudu Swedana in the form of Tapasweda using cloth soaked in hot water over Face ,neck & forehead for 5 min.)
| | 9 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ah.Su.20/10, Procedure details: patient will be made to lie in supine position on the table with head lower than body level[head low position].using dropper Brihatyadi Taila will be dropped 8 drops[one drop will be taken as 0.23ml]in each nostril.Then the patient will be asked to take deep inhalation.))
(1) Medicine Name: Madhukadi tail, Reference: Ah uttarsthan23/29, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 10 | Comparator Arm | Procedure | - | dhUmapAnam, धूमपानम् | (Procedure Reference: Ah.su21, Procedure details: patient will be made to lie in supine position on the table with head lower than body level[head low position].using dropper Brihatyadi Taila will be dropped 8 drops[one drop will be taken as 0.23ml]in each nostril.Then the patient will be asked to take deep inhalation.))
(1) Medicine Name: Dhoomvarti, Reference: Ah.su21, Route: Nasal, Dosage Form: Sprays, Dose: 3(NA), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fit For Nasya. 2.Both male and female of age group between 15 to 40 years. |
|
| ExclusionCriteria |
| Details |
1.Patients whose age is less than 15 and above 40 years. 2.Patient with symptoms of asadhya khalitya. 3.Patient suffering from any severe systemic disease. 4.Any prolonged debilitation associated Hair fall. 5.Necessary steps are taken to exclude other conditions as per facilities available in the institute. 6.patient having endocrine disorders,scalp psoriasis,patient who are taking chemo or radiation therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Visible improvement in sign and symptoms of Khalitya. 2.Assessment of the scalp with the help of Dermatoscope. |
5 to 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="42"
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)
|
15/11/2025 |
| 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="1"
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
|
Hair is one of Hair is one of the defining characterises mammals, human have around more than 2 million hair follicles which have both positive as well as negative effect on skin health. It is one of the vital 2 parts of our body which is derived from the ectoderm of the skin, it is work as a protective appendage for the body. Hair loss is silent but devasting problem which may occur to a healthy person also .khalitya or baldness according to great Aacharya Sushruta is a state of falling hair due to vitiated and increased state of Pitta assorted with Vayu, after that the Kapha mixed with Rakta also joins in this event.AcharyaCharak and Ashtang Hridayakar" have included Khalitya in Shiroroga on the basis of Rogasthana and etiopathogenesis of disease which is similar to that of Shiroroga Sushruta Samhita, Ashtanga Sangrah, Madhav Nidana and Yog Ratnakar has included Khalitya under Kshudrarog on basis of less severity and mildness of disease According to Acharya charak and. Sushrut and vagbbhat Nasya is indicated in shiroroga,, According to Ashtang Hridya Bruhatyadi taila is usefull in Khalitya Proper Authentication and standardization of raw Material and finished product will be done For Active controll Bruhtyadi Tail Nasya is used. The Study is divided into two arms Intervention arm - Marsha Nasya with Brihtyadi Tail comparator Arm - Marsha Nasya with Madhukadi Tail The Study is single Blind (Participant Blinded) Randomization will be done by using Computer Software 42 Sample Size is taken for each arm making it 84 The volunteers will ask for Marsh Nasya with 8/8 drops of taila for 7 days seven Days gap will be observed this will be repeated for 3 cycles Assessment of Khalitya will be done by reduction in signs and symptoms and images taken by Dermatoscope follow will be on 8th,15th,28th and 42nd Days in both groups. Statistical analysis and appropriate conclusion will be drawn |