| CTRI Number |
CTRI/2024/06/069456 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of shirahshooladi vajrarasa tablets in the treatment of vataja shiroroga( Tension typeheadache ) |
|
Scientific Title of Study
|
Efficacy of shirahshooladi vajra rasa in the management of vataja shiroroga with special reference to tension headache A controlled clinical trial |
| 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 Meghana B Patil |
| Designation |
Associate Professor and HOD |
| Affiliation |
Sanjeevini Ayurveda Medical College and Hospital, Gokul road, Hubballi, 580030 |
| Address |
Sanjeevini Ayurveda Medical College and Hospital
Department of Shalakyatantra Room No 6 Gokul Road Hubbali
Karnataka India
Dharwad
KARNATAKA
580030
India |
| Phone |
9916871886 |
| Fax |
|
| Email |
Drmeghanasanjeevini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghana B Patil |
| Designation |
Associate Professor and HOD |
| Affiliation |
Sanjeevini Ayurveda Medical College and Hospital, Gokul road, Hubballi, 580030 |
| Address |
Sanjeevini Ayurveda Medical College and Hospital Department of Shalakyatantra Room No 6 Gokul Nagar Hubli Dharwad Karnataka
Dharwad
KARNATAKA
580030
India |
| Phone |
9916871886 |
| Fax |
|
| Email |
Drmeghanasanjeevini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana B Patil |
| Designation |
Associate Professor and HOD |
| Affiliation |
Sanjeevini Ayurveda Medical College and Hospital, Gokul road, Hubballi, 580030 |
| Address |
Sanjeevini Ayurveda Medical College and Hospital Department of Shalakyatantra Room No 6 Gokul Nagar Hubli Dharwad Karnataka India
Dharwad
KARNATAKA
580030
India |
| Phone |
9916871886 |
| Fax |
|
| Email |
Drmeghanasanjeevini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevini Ayurveda Medical College and Hospital Hubballi Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sanjeevini Ayurveda Medical College and Hospital |
| Address |
Sanjeevini Ayurveda Medical College and Hospital
Vishwashrama Chetana (Dr K S Sharma Campus) basaveshwar nagar, Gokul Road Hubballi Karnataka India 580030
Gokul Road |
| Type of Sponsor |
Private 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 Meghana B Patil |
Sanjeevini Ayurveda Medical College and Hospital |
Sanjeevini Ayurveda Medical College and Hospital Department of Shalakyatantra Room No 6
Nagar Gokul Road Hubballi , Karnataka India 580030
Dharwad
KARNATAKA |
9916871886
Drmeghanasanjeevini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjeevini Ayurveda Medical College and Hospital Hubballi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shirahshooladi Vajra Rasa , Reference: Bhaishajyaratnavali vol 2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Bhaishajyaratnavali vol 2, Procedure details: sthanika swedana , mukhaabhyanga and instillation of taila in drop form follwed with kavala and dhoomapana )
(1) Medicine Name: shadbindutaila , Reference: Bhaishajyaratnavali vol2, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with the symptoms of Vataja Shiroroga
2. patients fulfilling the diagnostic criteria of ICHD 3 Beta |
|
| ExclusionCriteria |
| Details |
1. Migraine and cluster headache
2.Headache originating from the pathology of neighboring structure like ophthalmic,Ear Nose and Throat
3. Secondary Headache arsing from meningitis,tumors, cervical spondilitis etc
4.Preganacy, lactating mothers and other chronic illnesses
5.Patient unfit for nasya |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patients suffering from vataja shiroroga administered with the shirahshooladi vajra rasa will have improvement in the parameters like reduced intesity of pain, frequency and episodes. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of shirahshooladivajra rasa in reducing the frequency & intensity of headache in vataja shiroroga |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 controlled clinical trial to assess the efficacy of shirashooladi vajra rasa in the management of vataja shiroroga w.s.r to tension headache in the adults of age group 18 - 60 years of either gender with symptoms of vataja shiroroga and fulfilling diagnostic criteria of ICHD 3 beta which will be conducted in Sanjeevini ayurveda medical college and hospital, hubballi, Karnataka for a period of 1 year where the sujects will be enrolled based on the inclusion criteria and assessments of symptoms of vataja shirorga, Vas scale and Headache disability index will be done on 0th 8th 16th and 30th day later the obtained data will be recorded tabulated and analysed statistically where we expect shirashooladi vajra rasa is efective in vataja shiroroga. |