| CTRI Number |
CTRI/2025/04/084313 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Tension headache by Shiroabhyanga and Pratimarsha Nasya with Tila Taila |
|
Scientific Title of Study
|
Efficacy of Shiroabhyanga and Pratimarsha Nasya with Tila Taila in the management of Vataja Shirahshoola (Tension Headache)- A single Arm 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 |
BABARIA PALAK PRAVINBHAI |
| Designation |
MD scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantri Mandir Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
8200079046 |
| Fax |
|
| Email |
babariyapalak09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vd Arpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantri Mandir Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Vd Arpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Swasthavritta Dhanvantri Mandir Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar 361008 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opposite to Reliance Smart Near B Division Police Station Jamnagar 361008 Gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vd Palak Babaria |
Institute of Teaching and Research in Ayurveda |
OPD number 14 Department of Swasthavritta Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT |
8200079046
babariyapalak09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda INI Jamnagar |
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 | Procedure | - | Shiroabhyanga, Pratimarsha nasya | (Procedure Reference: Charaka Samhita Sutra Sthan Adhyay 5/81 and Ashtanga Hridaya Sutra Sthan 20/32, Procedure details: Shiroabhyanga with Tila Taila At morning in empty stomach For 5-10 min Pratimarsha Nasya with Tila Taila At morning after Shiroabhyanga & At evening before sunset (only Nasya) 2 drops in each Nostrils)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged between 18 to 60 years irrespective of the gender, cast, religion, occupation and financial status.
2.Patient willing to enrol for the study.
3.Patient having headache more than 3 months.
4.Patient having symptoms described in classical texts of Ayurveda and fulfilling ICHD-3 criteria
5. Shiroabhyanga and Pratimarsha Nasya Yogya as per classical texts. |
|
| ExclusionCriteria |
| Details |
1. Patient having age below 18 years and above 60 years.
2. Patient is not willing to enrol for the study.
3. Patient having history of head injury
4. Secondary headache caused by migraine, ocular pathology, acute and chronic sinusitis,
meningitis, encephalitis, cerebral abscess, intracranial tumour, cerebral haemorrhagic
condition, lumbar puncture.
5. Known case of Hypertension and diabetes mellitus type 1 and type 2, having any major
psychiatric illness
6. Pregnant women
7. Shiroabhyanga and Pratimarsha Nasya Ayogya as per classical texts. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in the symptoms of Vataja Shirahshoola(Tension headache).
2. Reduction in pain as measured by VAS score. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in the stress level as measured by Salivary cortisol, Galvenic skin resistance test
and Hamilton anxiety rating scale.
2. Improvement in QOL. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/06/2025 |
| 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="0" 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
|
Introduction:
Modern life stresses, including irregular diets,
workload, lack of sleep, and suppressed emotions, can drain the body and
lead to disease. Tension headache is one among them which can be
co-related with Vataja Shirahshoola described in Ayurvedic texts.
The common complaints regarding Shiroroga is Shirahshoola. Among
them Vataja Shirahshoola is most frequently caused by Tikshnapaana,
Vega Nigraha etc and psychogenic causes like Shoka
(grief), Bhaya (fear) are usually experienced by all human beings due to
their busy lifestyle. Shiroabhyanga and Pratimarsha Nasya
is the best procedure for prevention and management of Shirahshoola. One
who has got his head oleated well daily alleviates headache. Taila is
only ideal for daily use of Pratimarsha Nasya because the head is
dwelling place of Kapha and no Sneha other than Taila, can
keep it healthy. Utility of Tila Taila in various diseases and
its treatments, including massage, nasal administration is described in
classics, all types of oil pacify the Vata Dosha among them Tila
Taila is the best.
Rationale For Selection of Topic:
Now a days
lifestyle changes in human beings include unhealthy and irregular dietary
habits, intense workload and its pressure, suppression of natural urges,
irregular sleep cycle, sleepless night, inadequate relaxation, because of this
life has become very stressful with anxiety, worry, tension and depression. Due
to this stressful life many people usually suffer from headache. All type of headache
are primary but among them tension type headache disorder is very commonly seen
in people. Tension type headache often begins during teenage and affect 50%
more women than male. Tension headache is common, with a lifetime prevalence in
the general population ranging between 30% to 78%.
Aim and
Objective:
To evaluate the efficacy of Shiroabhyanga and Pratimarsha
Nasya with Tila Taila in the management of Vataja Shirahshoola
(Tension headache).
Materials and Methods:
50 patients
who are suffering from tension headache will be enrolled in this study.
Individual will recieve a Shiroabhyanga with Tila Taila
only in morning while empty stomach for approximately 5 to 10 minutes and Pratimarsha
Nasya with Tila Taila in morning after Shiroabhyanga
and in evening before sunset for 45 days.
Results and Discussion:
Data generated during the above
study will be present in a Systemic manner as shall be analyzed statically.
Where the important points
of the review of literature, Conceptual study, Analytical study will be discussed.
Follow up:
During the
treatment follow up will be done after every 15 days and After completion of
study, follow up will be done at 15th day to assess the status of patient. |