| CTRI Number |
CTRI/2024/10/074673 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Powder of Shwashkuthar Ras administered through the nasal route in patients with Tension-Type Headache |
|
Scientific Title of Study
|
Clinical study to Evaluate Efficacy and Tolerability of Shwashkuthar Ras (Pradhman Nasya) in Vatika Shiroroga
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha Nawani |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus UAU Haridwar |
| Address |
OPD No. 24 Department of Panchakarma Gurukul Campus UAU
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8979505188 |
| Fax |
|
| Email |
dhrusar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Bhatkoti |
| Designation |
Associate Proffessor |
| Affiliation |
Gurukul Campus UAU Haridwar |
| Address |
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand
Dehradun
UTTARANCHAL
249401
India |
| Phone |
08979505188 |
| Fax |
|
| Email |
mayankbhatkotimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Bhatkoti |
| Designation |
Associate Proffessor |
| Affiliation |
Gurukul Campus UAU Haridwar |
| Address |
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand
Dehradun
UTTARANCHAL
249401
India |
| Phone |
08979505188 |
| Fax |
|
| Email |
mayankbhatkotimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttaranchal 249401 |
|
|
Primary Sponsor
|
| Name |
Gurukul Campus UAU Haridwar |
| Address |
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand 249401 |
| 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 Pratibha Nawani |
Gurukul Campus Uttarakhand Ayurved University Haridwar |
OPD No 24 Department of Panchakarma Gurukul Campus UAU Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
8979505188
dhrusar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Uttarakhand Ayurved University Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: SIRORUKÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pradhamanam/ dhmApanam, पà¥à¤°à¤§à¤®à¤¨à¤®à¥/ धà¥à¤®à¤¾à¤ªà¤¨à¤®à¥ | (Procedure Reference: Yogratnakar Shirorogadhikar, Procedure details: Pradhman Nasya with Shwasakuthar Ras will be given in 2 courses of 14 days on
alternate days, with a gap of 7 days.)
(1) Medicine Name: Shwashkuthar Ras, Reference: Yogratnakar Shwashchikitsa Vidyotini Pg. 435, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients from the Age group between 20-50.
2)Patient will be selected irrespective of sex, religion, occupation etc.
3)Patients with classical signs and symptoms of Vatika Shiroroga will be selected from
OPD and IPD of Gurukul campus hospital UAU Haridwar.
4)Patients fulfilling ICHD3 criteria for Tension-Type of Headache
5) Patients previously treated with medicines or therapies for Vatika Shirorog |
|
| ExclusionCriteria |
| Details |
1)Known case of Sinusitis
2)Any other types of infections associated with fever.
3) Any pathology involving the eyes.
4) Uncontrolled Hypertension
5) Diabetes mellitus
6)Migraine, Cluster headache, Trigeminal neuralgia
7)Known cases of Seizures
8)Any other serious systemic illness.
9)Secondary headache arising due to meningitis, tumor, cervical spondylosis, etc.
10) Patients who are intolerant to Pradhman Nasya |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Subjective Parameters like:
1) Bitemporal Headache
2) Pain in the Occipital Region
3) Pain and burning in the Frontal region
4) Pain in eyes as if eyes are coming out
5) Severe Pain in the Ears
6) Giddiness
7) Pain as if joints are laxed
8) Disturbed sleep
9) Excessive pain at night
|
1st day,35 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Vatika Shiroroga |
1st, 35th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="6"
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 single-arm, open-label trial for the Efficacy and Tolerability of Shwashkuthar Ras Pradhman Nasya in Vatika Shiroroga. This study will be conducted at UAU Gurukul Campus Haridwar in 30 Patients. The assessment will be done based on Subjective Parameters. The study will be conducted at the OPD/IPD level of the PG Department of Panchakarma. |