| CTRI Number |
CTRI/2023/02/049613 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of sitopalamadana yoga as nasya in Ardhavbhedaka. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of sitopalamadana yoga for nasya in Ardhavabhedaka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrunal Bhimrao Govardhan |
| Designation |
1st year PG Scholar (panchakarma department) |
| Affiliation |
Yashwant Ayurvedic College and Hospital. |
| Address |
Ground floor of Panchakarma Department,Yashwant Ayurvedic
College and hospital kodoli,Tal-Panhala,Dist-kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7218174000 |
| Fax |
|
| Email |
dr.mreenalgovardhan2106@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Patil |
| Designation |
Head of the Department (Panchakarma Department) |
| Affiliation |
Yashwant Ayurvedic College and Hospita kodoli,tal-panhala,dist-kolhapur |
| Address |
Panchakarma department,second floor, Yashwant Ayurvedic College and hospital kodoli,Tal-Panhala,Dist-kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822010316 |
| Fax |
|
| Email |
vaidyaravipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrunal Bhimrao Govardhan |
| Designation |
1st year PG Scholar (panchakarma department) |
| Affiliation |
Yashwant Ayurvedic College and Hospital |
| Address |
Panchakarma department, Yashwant Ayurvedic College and hospital kodoli,Tal-Panhala,Dist-kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7218174000 |
| Fax |
|
| Email |
dr.mreenalgovardhan2106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College and hospital kodoli, kolhapur |
|
|
Primary Sponsor
|
| Name |
Mrunal Bhimrao Govardhan |
| Address |
Yashwant ayurvedic College and hospital kodoli,kolhapur
tal-panhala, Dist-kolhapur |
| 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 |
| Mrunal Bhimrao Govardhan |
Yashwant Ayurvedic College and Hospital |
Prakriti Panchakarma and wellness center,Yashwant Ayurvedic College and Hospital
Kodoli ,tal-Panhala,dist-
kolhapur 416114
Kolhapur
MAHARASHTRA |
7218174000
dr.mreenalgovardhan2106@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Yashwant Ayurvedic College and hospital kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R51||Headache. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sitopalamadana yoga , Reference: Yogaratnakara , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 08(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhrungrajadi Tail , Reference: Charak , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 08(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms The diagnosis of the disease was done on the basis of clinical manifestations like attacks of headache, mostly unilateral in nature, variable in intensity, frequency and duration with or without nausea, vomiting, and vertigo |
|
| ExclusionCriteria |
| Details |
1)People above age of 50 year
2)Patients suffering from major disease e.g.tuberculosis, cancer, diabetes- mellitus, heartdisease, hypertension etc.
3)Pregnant and lactating women
4)Women who is under the menstrual cycle |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of attacks of headache, mostly unilateral in nature, variable in intensity, frequency and duration with or without nausea vomiting and vertigo |
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the symptoms of attacks of headache, mostly unilateral in nature, variable in intensity, frequency and duration with or without nausea vomiting
VAS(visual analog scale)-graded starting from pain to absence of pain |
14th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2023 |
| 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="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients presenting with signs and symptoms like attacks of headache, mostly unilateral in nature, variable in intensity, frequency and duration with or without nausea, vomiting, and vertigo patient suffering from migraine.Nasya is an important treatment mentioned in samhitas for patients with above symptoms hence, this treatment is advised to improve in symptoms of Ardhavabhedaka (Migraine). |