CTRI

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CTRI Number

CTRI/2025/02/080644 [Registered on: 17/02/2025] Trial Registered Prospectively

Last Modified On:

12/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Clinical evaluation of efficacy of Rasnadashamoola kwatha in the management of Ardhavabhedhaka(Migraine).

Scientific Title of Study

A Randomized controlled clinical study to evaluate the efficacy of Rasnadashamoola kwatha over Pathyadi kwatha in the management of Ardhavabhedhaka (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 SAMPREETA A S
Designation	PG Scholar
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal Padma Ayurvedic Hospital And Research Centre. Dr Siddhant Nagar, Terdal Bagalkot KARNATAKA 587315 India
Phone	9113975061
Fax
Email	sampuas7@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sukumar Nandigoudar
Designation	Professor
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal Bagalkot KARNATAKA 587315 India
Phone	9986125625
Fax
Email	vaidyasukumar@gmail.com

Details of Contact Person
Public Query

Name	DR SAMPREETA A S
Designation	PG Scholar
Affiliation	Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
Address	OPD Department Of Kayachikitsa Ground Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre, Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal Padma Ayurvedic Hospital And Research Centre. Dr Siddhant Nagar, Terdal Bagalkot KARNATAKA 587315 India
Phone	09113975061
Fax
Email	sampuas7@gmail.com

Source of Monetary or Material Support

SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka

Primary Sponsor

Name	DR SAMPREETA A S
Address	SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal 587315 Karnataka
Type of Sponsor	Other [SELF]

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 SAMPREETA A S	Padma Ayurvedic Hospital And Research Centre	OPD Department of Kayachikitsa Ground Floor Padma Ayurvedic Hospital And Research Centre, Terdal 587315 Bagalkot KARNATAKA	9113975061 sampuas7@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital INSTOTUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:G439\|\|Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Pathyadi Kwatha, Reference: Yogaratnakara Shiroroga Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Rasnadashamoola Kwatha, Reference: Bhaishajya Ratnavali Vatavyadhi Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	16.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1 Subjects aged between 16-60 years of either gender. 2 Subjects fulfilling the Diagnostic criteria of Ardhavabhedaka (Migraine) 3 Subjects of Migraine without Aura. 4 Both Fresh and treated cases will be considered for study. 5 Subjects who are willing to sign the Consent.

ExclusionCriteria

Details

1 Diagnosed cases of Anantavata (Trigeminal Neuralgia), Suryavartha, Dustapratishyaya (Chronic Sinusitis).
2 Subjects having a history of severe head injury.
3 Subjects with known systemic disorders [like- Uncontrolled hypertension, Cardiac problems] which interfere the intervention of Study.
4 Known cases of psychological disorder.
5 Subjects of Migraine with Aura
6 Any other illness which the researcher feels that interferes the intervention of study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Effect of Trial drug on improvement in classical symptoms of Ardhavabhedaka (Migraine)	7day,15day,30day

Secondary Outcome

Outcome	TimePoints
Safety of the trial drug and adverse drug reaction and aggravation in the symptoms of Ardhavabhedaka (Migraine)	7day,15day,30day

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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 3

Date of First Enrollment (India)

25/02/2025

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

Migraine is a common clinical problem characterized by unilateral throbbing, pulsating type of headache associated with vomiting, nausea, photophobia and Phonophobia. Which is very well correlated with Ardhavabhedaka explained in Ayurvedic classics.

Ardhavabhedaka is a clinical manifestation with dominancy of Vata and kapha dosha which produces cardinal symptoms like Ardhashirashula along with unilateral sever pain in Manya, Bhru, Shanka, Karna, Akshi and Lalata Pradesha. The pain episodes may be seen once in a month /15 days/10 days/suddenly at any time.

The incidence of migraine is at peak due to stressful life, Busy schedule and Altered Dietary habits. According to data from WHO, migraine is the third most prevalent medical condition. Prevalence of migraine usually starts after puberty and continues until middle and late ages of life. Frequency of occurrence is more common in females than males, in females 17% and in males 6% Yearly.

Here is an attempt to evaluate the efficacy of Rasnadashamula Kwata which is having properties like Vatakaphahara, Vedhanasthapana, Deepana, Pachana, and Shirorujahara, explained in Bhaishajya Ratnavali Vatavyadhi Chikitsa and its efficacy is compared with a control drug Pathyadi Kwata explained in Yogaratnakara Shiroroga Chikitsa.