| CTRI Number |
CTRI/2025/03/081686 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Nasya with 0.5ml Shwadanstradi Tail in Ardhavabhedak patient of age 18 to 60 year |
|
Scientific Title of Study
|
Randomised uncontrolled clinical study to evaluate the efficacy of Shwadanstradi Tail nasya in ardhavabhedak with special reference to Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrunali Ramchandra Gavade |
| Designation |
PG student (Panchakarma ) |
| Affiliation |
LKR Ayurvedic college and research center |
| Address |
Panchakarm Department, ground floar, room number 3,LKR hospital P2 MIDC area Shendri Mall
P2 MIDC area Shendri Mall, Gadhinglaj, kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7770040470 |
| Fax |
|
| Email |
mrg18812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Patil |
| Designation |
MD PANCHAKARMA |
| Affiliation |
LKR Ayurvedic college and Research center |
| Address |
Panchakarm Department, ground floar, room number 3,LKR hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9823347244 |
| Fax |
|
| Email |
drsachinayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrunali Ramchandra Gavade |
| Designation |
PG student (Panchakarma) |
| Affiliation |
LKR Ayurvedic college and Research center |
| Address |
Panchakarm Department, ground floar, room number 3,LKR hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7770040470 |
| Fax |
|
| Email |
mrg18812@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late kedari Redekar Ayurvedic college and Research center Tal-Gadhinglaj Dist-kolhapur
State- Maharashtra Country- India, Pin code- 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Mrunali Ramchandra Gawade |
| Address |
At post - Gijavane
Tal - Gadhinglaj
Dist- Kolhapur
State- Maharashtra
Country- India
Pincode- 416502 |
| 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 Mrunali Ramchandra Gavade |
LKR Ayurvedic college and Research center Gadhinglaj |
Panchakarm Department ground floar, room number 3,LKR hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur 416502
Kolhapur
MAHARASHTRA |
77700 40470
mrg18812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKR Ayurvedic college and Research center Gadhinglaj Dist- Kolhapur, state- Maharashtra, Country- India, Pincode- 416502 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G09||Sequelae of inflammatory diseasesof central nervous system. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwadanstradi Tail , Reference: Charak samhita Chikitsasthan 28/146,147, Route: Nasal, Dosage Form: Taila, Dose: 0.5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Nasya given for continew 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting sign and symptoms of Ardhavbhedaka like attack of headache Mostly unilateral in nature,variable in Intensity, frequency and duration with and without nausea. |
|
| ExclusionCriteria |
| Details |
Hypertension, DM,women under menstrual cycle, pregnant and lactating mother,women having headache 4 to 5 days before menstrual cycle. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Shwadanstradi Tail Nasya in Ardhavabhedak |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Shwadanshtradi Tail
To study Ardhavabhedak |
7 Days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="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
|
This study is randomised uncontrolled clinical study to evaluate efficacy of Shwadanstradi Tail nasya in ardhavabhedak with special reference to Migraine. Total 60 patients of age 18 to 60 of both sex will be selected and Shwadanstradi tail nasya is given for 7 days. Data will be analysed and appropriate statistical test will be applied , result will be presented |