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CTRI Number  CTRI/2025/11/096912 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study on Ayurvedic Treatment for Ardhavbhedaka (Migraine) Using Laghu Sutshekhar Ras, Anu Taila Nasya and Pathyadi Kwath 
Scientific Title of Study   A Single Arm Open Label Clinical Study to Evaluate the Efficacy of Laghu Sutshekhar Ras and Anu Taila Nasya along with Pathyadi Kwath in the Management of Ardhavbhedaka (Migraine) 
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 Vandana Saini 
Designation  PG Scholar MS Shalakya Tantra 
Affiliation  Institute for Ayurved Studies and Research Kurukshetra Haryana 
Address  OPD No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  7696015642  
Fax    
Email  vandanasaini942@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Kumar  
Designation  Professor , Department of Shalakya Tantra 
Affiliation  Institute for Ayurved Studies and Research Kurukshetra Haryana 
Address  Room no 109 PG Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9996310888  
Fax    
Email  drmanojtanwar23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vandana Saini 
Designation  PG Scholar MS Shalakya Tantra 
Affiliation  Institute for Ayurved Studies and Research Kurukshetra Haryana 
Address  OPD No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  7696015642  
Fax    
Email  vandanasaini942@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Sector 8 Kurukshetra, Haryana, India Pincode 136118 
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research  
Address  Umri Road Sector 8 Kurukshetra  
Type of Sponsor  Other [Government Ayurvedic College] 
 
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 Vandana Saini  Institute for Ayurved Studies and Research Hospital   OPD No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana Kurukshetra HARYANA 136118 India
Kurukshetra
HARYANA 		 7696015642

vandanasaini942@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Samhita Vidyotini, Sutra Sathana 5 for Anu Taila Prepration. , Procedure details: Procedure will be done for 21 days 3 Sittings of Nasya i.e 7days each with an interval of 7 days in between. )
(1) Medicine Name: Anu Taila, Reference: Charak Samhita Vidyotini, Sutra Sathana 5 , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 21 Days
2Intervention ArmDrugClassical(1) Medicine Name: Laghu Sutshekhar Ras, Reference: Rasatantra Sara Siddha Prayog Sangrah , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Pathyadi Kwath, Reference: Bhavaprakash madhyamkhanda ,Shirorogadhikar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: - Guda), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with sign and symptoms of Ardhavabhedaka (Migraine with or without aura) will be selected irrespective of Sex, Religion and Profession.
Patients those are fit for Nasya Karma according to Ayurveda text.
Patients who have given written consent to participate in the study.
 
 
ExclusionCriteria 
Details  Age group less than 18 years and more than 50 years.
The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, Hypotension & fever etc.
Patients suffering from head injury, and other type of headaches except migraine.
Patients Contraindicated for Nasya Karma.
Patients unwilling to provide written consent for participation are excluded.
Pregnant and lactating mothers.
Secondary headache caused by sinusitis, meningitis, brain tumour, encephalitis, cervical spondylitis etc.
Patients with any inflammatory disease.
Patients requiring surgical treatment (eg- for nasal polyp).
Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in signs and symptoms of Ardhavbhedaka (Migraine).

 		 Follow up of patient will be done on 15th, 35th day of the treatment.


 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in mental & physical well being of patient.   Follow up on 15th , 30th day after treatment .

 
 
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)   01/12/2025 
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 present study entitled A Single Arm Open Label Clinical Study to Evaluate the Efficacy of Laghu Sutshekhara Ras and Anu Taila Nasya along with Pathyadi Kwath in the Management of Ardhavbhedaka (Migraine) will be conducted to assess the effectiveness of Ayurvedic formulations in relieving migraine symptoms.

 Ardhavbhedaka, described in Ayurvedic texts, closely resembles migraine, which is characterized by recurrent unilateral headaches often accompanied by nausea, vomiting, and photophobia. 
In this study, patients diagnosed with Ardhavbhedaka will be treated with Laghu Sutshekhara Ras orally, Anu Taila Nasya as nasal therapy, and Pathyadi Kwath as an adjuvant for a specific duration. The study will be conducted on 30 patients from opd/ipd of Institute for Ayurved Studies and Research Hospital, Kurukshetra Haryana.

The study follow a single-arm, open label design, allowing direct observation of therapeutic outcomes. Assessment will be done before and after treatment based on the frequency, duration, and intensity of headache attacks, as well as associated symptoms.
 
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