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CTRI Number  CTRI/2024/11/076378 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Pankajakasthuri Migraine Oil in Reducing Migraine Headache Symptoms Among Adults: A Clinical Study 
Scientific Title of Study   An open labeled single arm clinical trial on the Efficacy of Pankajakasthuri Migraine Oil in 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 J Hareendran Nair  
Designation  Managing Director and Founde 
Affiliation  Pankajakasthuri Herbal Research Foundation  
Address  Room No:1 Department of Research and Development, Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum

Thiruvananthapuram
KERALA
6695572
India 
Phone    
Fax    
Email  hareendrannair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aiswarya P 
Designation  Director 
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre  
Address  Room No:1 Department of Shalayak tantra, Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9900141246  
Fax    
Email  aiswarya@pkhil.com  
 
Details of Contact Person
Public Query  
Name  Dr Kasthuri Nair A  
Designation  Director  
Affiliation  Pankajakasthuri Ayurveda Medical college and PG centre 
Address  Room No:1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  8113851665  
Fax    
Email  dr.kasthurinair@pkhil.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Trivandrum, Kerala, India Pin: 695575 
 
Primary Sponsor  
Name  Pankajakasthuri Herbals India Pvt Ltd  
Address  Poovachal Trivandrum Kerala, India Pin: 695575 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Anu PV  Pankajakasthuri Ayurveda Medical College & PG Centre  Room NO 2, Department of Shalakya tantra, Pankajakasthuri Ayurveda Medical College & PG Centre Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 		 7558841256

anuvikraman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G89||Pain, not elsewhere classified. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Annabhedi Sindooram, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: lime juice-), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: 18-60 years
2. Diagnosis of migraine
3. Both fresh and previously treated cases will be considered
4. Subjects of any sex
5. Migraine attacks occurring 1-6 times per month
6. History of migraine attacks for over one year
 
 
ExclusionCriteria 
Details  1. Subjects diagnosed with other primary headache disorders
2. Referred pain due to eye, ear, nose, throat, or dental disorders
3. Systemic disorders that could interfere with treatment outcomes
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the severity and frequency of migraine headaches   The severity of migraines will be assessed using a validated scale, such as the Visual Analog Scale (VAS) or the Migraine Disability
 Baseline: Prior to treatment initiation (Day 0).
 30 Days: Post-treatment, patients will report the severity and frequency of migraines.
 90 Days: Follow-up assessment to determine sustained changes.
 180 Days: Long-term assessment of treatment effectiveness.
 
 
Secondary Outcome  
Outcome  TimePoints 
• Changes in nausea, photophobia, phonophobia, and quality of life assessed at baseline and after six months of treatment.
• Adverse effects will be monitored throughout the study period, and any reports will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).
 		 Changes in Nausea, Photophobia, Phonophobia, and Quality of Life will be assessed on 30 days, 90 days, and 180 days.
• Adverse effects will be tracked throughout the study period via patient-reported outcomes and clinician observations. Adverse events will be documented at each follow-up (30 days, 90 days, and 180 days).
 
 
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)   18/11/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Migraine is a prevalent and debilitating neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by nausea, vomiting, and sensitivity to light and sound. This condition not only impairs individual quality of life but also contributes to significant healthcare burdens globally. Current treatments, primarily analgesics and triptans, can result in adverse effects and are not universally effective. This study aims to evaluate the efficacy of Pankajakasthuri Migraine Oil, an Ayurvedic formulation, in managing migraine without aura. A total of 40 subjects diagnosed with migraine without aura will be recruited from the outpatient department (OPD) of Pankajakasthuri Ayurveda Medical College and Hospital in Kattakada, Thiruvananthapuram. Participants will receive Pankajakasthuri Migraine Oil for six months, with assessments based on the severity, duration, and frequency of migraine attacks, as well as accompanying symptoms such as nausea, photophobia, and phonophobia. Quality of life will also be evaluated using established metrics. 
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