| CTRI Number |
CTRI/2026/01/102196 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Shalparni Avapidan Nasya In Ardhavbhedaka |
|
Scientific Title of Study
|
Efficacy Of Shalparni Avapidan Nasya In The Management Of Ardhavbhedaka - A Single Arm Study. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitendra Atmaram Bhadane |
| Designation |
PhD Scholar, Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre |
| Address |
1st Floor, Panchakarma department, LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre, Islampur-Sangli Road, Islampur, Tal.-Walwa, Dist.-Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9224256171 |
| Fax |
|
| Email |
dr.hitendrabhadane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Raghab Parida |
| Designation |
Professor and Head Of Department |
| Affiliation |
LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre |
| Address |
1st Floor, Panchakarma department, LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre, Islampur-Sangli Road, Islampur, Tal.-Walwa, Dist.-Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitendra Atmaram Bhadane |
| Designation |
PhD Scholar, Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre |
| Address |
1st Floor, Panchakarma department, LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre, Islampur-Sangli Road, Islampur, Tal.-Walwa, Dist.-Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9224256171 |
| Fax |
|
| Email |
dr.hitendrabhadane@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College, Hospital, Post Graduate Institute & Research Centre, Islampur, Sangli - 415409, Maharashtra, India. |
| YMT Ayurvedic Medical College & Hospital, Kharghar, Navi Mumbai - 410210, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr. Hitendra Atmaram Bhadane |
| Address |
Flat No.-103, Sai-Leela C.H.S.,
Plot No.-25, Sector No.-21,
Kharghar,
Tal.-Panvel, Dist.-Raigad,
Navi Mumbai- 410210. |
| 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 Hitendra Atmaram Bhadane |
YMT Ayurvedic Medical College & Hospital |
Panchkarma Department,
OPD No.-07,
YMT Ayurvedic Medical College & Hospital,
Institutional Area,
Sector No.-04,
Kharghar,
Navi Mumbai- 410210.
Raigarh
MAHARASHTRA |
9224256171
dr.hitendrabhadane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT Ayurvedic Medical College & Hospital, Kharghar, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Vangasen Samhita Shirorogadhikara 102, Procedure details: Purva Karma - Prior to Nasya Snehan will be done on face, forehead, ears, & neck with
Tila Tail for approximately for 10 minutes.
Sthanik Tap Swedan will be done with the help of Cotton cloth for
10mins.
Pradhan Karma – Position Supine position with slightly extended neck.
The extracted Shalparni swaras drug will be instilled into one nostril
while other nostril kept closed the same process is carried out in other
nostril also.
For administration of drug dropper will be used.
5 mins rest in supine position the drug which is coming in the throat will
be told to expel (spit) out from mouth in the kidney trey.
Paschat Karma – Prayogik Kaval with plain warm water will be given for 5 mins till patient
feels complete evacuation of drug from the throat.)
(1) Medicine Name: Shalparni, Reference: Vangasen Samhita Shirorogadhikara 102, Route: Nasal, Dosage Form: Swaras/ Juice, Dose: 4(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing classical lakshanas of Ardhavbhedaka. |
|
| ExclusionCriteria |
| Details |
1) Patients of Ardhavbhedaka taking other treatment for other disease presently.
2) Patients suffering from Hypertension, DM, Hyper & Hypo Thyroidism, COPD and
other chronic disease.
3) Patients suffering from secondary headaches like meningitis, brain tumor,
encephalitis, cervical spondylosis, refractive errors & glaucoma.
4) Patients suffering from all types of sinusitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the aetiophathogenesis and progress of Ardhavbhedaka with special
reference to diagnostic parameters of Ayurved texts. |
baseline, 1 week and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the procedure of Avapiodan nasya in details. |
baseline, 1 week and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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
|
N/A |
|
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="2"
Months="0"
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
|
The present study is a PhD Topic. By PhD Scholar - Dr. Hitendra Atmaram Bhadane and Guide Name - Dr. D.K. Parida.
Title - Efficacy Of Shalparni Avapidan Nasya In The Management Of Ardhavbhedaka - A Single Arm Study.
DOSE OF DRUG : Shalparni avapidan nasya
Route of administration :- Nasal
Matra :- Total 8 Bindus (3.6ml) means 4 Bindu (1.8ml) in each nostril
Duration : After 1st visiting day (Day 0) of patient, Nasya will be started from next day morning and will be continued for 7 days followed by After treatment (AT)-1 assessment on 7th Day, followed by followed by Follow Up on 30th day.
DURATION OF STUDY : Total duration of study will be 24 Months.
|