| CTRI Number |
CTRI/2025/06/089902 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Marma Chikitsa and Bala Taila Nasya ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma Chikitsa In Vatika Shirahshoola With Special Reference To Tension Headache |
|
Scientific Title of Study
|
A Comparative Study On Efficacy Of Marma Chikitsa And Bala Taila Nasya In The Management Of Vatika Shirahshoola With Special Reference To Tension Headache |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pinky Billore |
| Designation |
MD Scholar Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7389793078 |
| Fax |
|
| Email |
billorepinky@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swatantra Kumar Chourasia |
| Designation |
Reader Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109359509 |
| Fax |
|
| Email |
drswatantrachourasia.2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pinky Billore |
| Designation |
MD scholar Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda Collage And Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7389793078 |
| Fax |
|
| Email |
billorepinky@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Pinky Billore |
Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh |
PG Department Of Rachna Sharir Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
7389793078
billorepinky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pandit Khushilal Sharma Government Autonomous Ayurveda Collage And Institute Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marma Stimulation Once A Day For 15 Days)
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marma Chikitsa And Nasya Karma Once A Day For 7 Days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Of Either Sex In The Age Group 20 TO 60 Year
Patients Presenting Classical Features Of Vatika Shirahshoola
Patients Fulfilling Diagnostic Criteria
Patients Willing To Be Registered For Study
|
|
| ExclusionCriteria |
| Details |
Patients Not Suitable For To Nasya Karma
Severe Referred Pain In One Half Of The Head Due To Disorder Of Eye Ear Nose Throat Teeth Will Be Excluded
Patients Presented With Other Types Of Headaches Like Migraine Cluster Headache Sinus Headache Neuralgia
Patients Suffering From Diabetes Tuberculosis Cardiovascular Disease Malignancy Any Psychiatric Disease And Or Any Other General Debilitating Health Conditions
Patients Who Needs Surgical Intervention Patient Not Willing To Be Registered For Study Pregnant And Lactating Women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It Is Expected That At The End Of The Study Scholar Will Be Able To Evaluate The Effect Of The Marma Chikitsa And Bala Taila Nasya In The Management Of Vatika Shirahshoola With Special Reference To Tension Headache |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa Is Non Pharmaceutical Approach To Treat Vatika Shirahshoola With Special Reference To Tension Headache |
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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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
|
The Study Compares The
Effectiveness Of Two Ayurvedic Treatments For Vatika
Shirahshoola With Special Reference To Tension Headache
Treatment Groups
Group 1 Marma Chikitsa- 20 Patients Of This Group Will Be Treated With
Marma Chikitsa, Once A Day.
Group 2 Nasya Karma With
Bala Taila- 20 Patients Of This Group Will Be Given Nasya With Bala Taila Once
A Day.
In This Study The Assessment Has Done On The Basis Of Subjective And Objective
Parameter Of Vatika Shirahshoola Expected Outcome The Study Aims To Determine Which Treatment
Is More Effective In Managing Vatika Shirahshoola
|