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CTRI Number  CTRI/2024/07/070740 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Vatika Shirashoola (Tension type headache) 
Scientific Title of Study   A Randomized Comparative Clinical Study to Evaluate the Effect of Ksheerbala Taila Nasya and Varanadi Ghrita Nasya along with Go- Ghrita Pana in the Management of Vatika Shirashoola/Tension-type Headache 
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 Chanchal 
Designation  PG Scholar 
Affiliation  Institute for Ayurved Studies and Research 
Address  OPD Room no. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7404741210  
Fax    
Email  chanchalchaudhary987@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Kumar 
Designation  Associate professor 
Affiliation  Institute for Ayurved Studies and Research 
Address  Room No. 109, PG Dept of Shalakya Tantra Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  9996310888  
Fax    
Email  drmanojtanwar23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chanchal 
Designation  PG Scholar 
Affiliation  Institute for Ayurved Studies and Research 
Address  OPD No. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7404741210  
Fax    
Email  chanchalchaudhary987@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research, Umri road, Sec 8, Kurukshetra Haryana (136118) India 
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research 
Address  Sector-8 Umri Road Kurukshetra 136118 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chanchal  Institute for Ayurved Studies and Research Hospital  Room No. 50, Shalakya Tantra (ENT OPD) KNMS,, Sector-8 Umri Road Kurukshetra 136118
Kurukshetra
HARYANA 
7404741210

chanchalchaudhary987@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee on Human Research of ICMR, New Delhi  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-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sharangdhar Samhita, Procedure details: Marsha Nasya with Varanadi ghrita . Go-ghrita pana 10 ml at night after meal. (3 sittings 7 day each with an interval of 7 days in between))
(1) Medicine Name: Varanadi Ghrita, Reference: Ashtang Hridaya, Route: Nasal, Dosage Form: Ghrita, Dose: 2.7(ml), Frequency: od, Duration: 35 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sharangdhar Samhita, Procedure details: Marsha Nasya with Ksheerbala taila along with Go-ghrita pana 10 ml at night after meal. (3 sittings 7 day each with an interval of 7 days in between))
(1) Medicine Name: Ksheerbala Taila, Reference: Ashtang Hridaya, Route: Nasal, Dosage Form: Taila, Dose: 2.7(ml), Frequency: od, Duration: 35 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age- 16-60 years
2) Patients with sign and symptoms of Vatika Shirashoola (Tension Type Headache) will be selected irrespective of Sex, Religion and Profession.
3) Patients those are fit for Nasya Karma according to Ayurveda text. 
 
ExclusionCriteria 
Details  1) The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, Anaemia, Hypotension & fever etc.
2) Patients suffering from head injury, and other type of headaches except tension type headache.
3) Patients Contraindicated for Nasya Karma.
4) Pregnant and lactating mothers.
5) Individuals suffering from general debilitating health condition, immunocompromised disease or on immunosuppressive drugs.
6) Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
7) Patients not willing to be registered for clinical study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in the hematological findings i.e. TLC, DLC, ESR and Hb%.
2.Changes in the opthalmological findings.
 
36th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction sign and symptoms of Vaatika Shirashoola.
 
70th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/08/2024 
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  

Vatika Shirashoola is most frequently seen because of the vata prakopaka nidanas like ucchabhasana, tikshna madyapana, ratri jagarana, vegadharana, langhana, aaghata ,shoka, bhaya, chinta, characterized by pricking pain at shankha pradeshaghata sambidhyate (cutting type of pain in posterior aspect of neck), tapa (burning sensation and pain in forehead) and ativedana in bhru madhye and lalata,vadhyetae swanataha (noise heard by the patient in both ear),srotro niskrusyatae(loss of hearing power), nishkruhsyete ivaakshini (feeling of eyes extruded outwards),sarva sandhi muchanam(there is giddiness and the joints are severed as it where), sphuratyati sira jalam (excessive throbbing of the vein with pulsation). In Vataja Shiro roga, ratrikala ati vedana is present i. e. pain aggravates severely in night and is relieved by binding and fomentation. Tension Type Headache can be compared with Vatika Shirashoola described in Ayurvedic texts, as psychological factors like excessive weeping, fear, terror have also been attributed in its sampraptiIn Ayurveda, the Acharyas have recognized the importance of medicines, especially of the herbal medicines. There is no permanent treatment of tension type headache in modern therapy. Treatment protocol is not fixed as no unique etiology, pathogenesis and diagnosis criteria is known. Hence there is a need to develop safe and permanent treatment for TTH. Drugs having Urdhvajatrurogahara and Vatahara properties are added choice in the management of Vatika Shirashoola. So Vatahara properties of Ksheerbala tailaVaranadi ghrita and Go- Ghrita is the reason behind the selection of drug amongst the medicinal heritage of traditional Indian medicine. This study gives importance to break the Samprapti of the disease through Shamana process. Nasya is considered as the best procedure in all Urdhvajatrugata rogas. Hence in present study, Nasya with Varanadi ghrita and Ksheerbala Taila along with Go-Ghrita pana is considered.

 
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