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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  
Name  Address 
Nil   
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: VATAJA-SIROROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.

 
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