CTRI

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CTRI Number

CTRI/2026/01/100229 [Registered on: 02/01/2026] Trial Registered Prospectively

Last Modified On:

01/01/2026

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

A study to see how vidhakarma (needle pricking therapy) and Pathyadi kashaya tablet help in migraine headache

Scientific Title of Study

A randomized open label double arm controlled clinical study to evaluate the efficacy of Viddhakarma and Pathyadi Kashaya tablets 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 Pooja Soni V
Designation	PG Scholar
Affiliation	SDMIAH, Bangalore
Address	Department of Shalakya Tantra, SDM Institute of Ayurveda and Hospital, Kumbalgodu Post, Anchepalya, Challegatta, Bengaluru Karnataka NIL Bangalore KARNATAKA 560074 India
Phone	8075854628
Fax
Email	poojasoniv24@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Mamatha K V
Designation	Professor and Head of Department
Affiliation	SDMIAH, Bangalore
Address	Department of Shalakya Tantra SDM Institute of Ayurveda and Hospital, Kumbalgodu Post, Anchepalya, Challegatta, Bengaluru Karnataka Bangalore KARNATAKA 560074 India
Phone	9845393236
Fax
Email	mamatha.sova@gmail.com

Details of Contact Person
Public Query

Name	Dr Mamatha K V
Designation	Professor and Head of Department
Affiliation	SDMIAH, Bangalore
Address	Department of Shalakya Tantra SDM Institute of Ayurveda and Hospital, Kumbalgodu Post, Anchepalya, Challegatta, Bengaluru Karnataka KARNATAKA 560074 India
Phone	9845393236
Fax
Email	mamatha.sova@gmail.com

Source of Monetary or Material Support

SDM Institute of Ayurveda and Hospital

Primary Sponsor

Name	SDM Institute of Ayurveda and Hospital
Address	SDM Institute of Ayurveda and Hospital Kumbalgodu Post Bengaluru Karnataka PIN-560074 India
Type of Sponsor	Private medical 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 Pooja Soni V	SDMIAH, Bangalore	Department of Shalakya Tantra SDM Institute of Ayurveda and Hospital, Kumbalgodu Post, Anchepalya, Challegatta, Bengaluru Karnataka Bangalore KARNATAKA	8075854628 poojasoniv24@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	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

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Pathyadi kashaya tablet, Reference: Shasthri Parashuram V,editor.The Sarangadhara samhitha with the commentaries Adhamalla’s Dipikaand Ksiramasgudarthadipika,Madhyama chap2,verse143.Varanasi: Chowkhamba krishnadas academy, p. 162, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Vidhakarma with no.26 needle during pain phase of Migraine in alternate days for 7 days
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Pathyadi kashaya, Reference: Shasthri Parashuram V,editor.The Sarangadhara samhitha with the commentaries Adhamalla’s Dipikaand Ksiramasgudarthadipika,Madhyama chap2,verse143.Varanasi: Chowkhamba krishnadas academy, p. 162, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: 3g Guda), Additional Information: Vidhakarma with no. 26 needle during pain phase of Migraine on alternate days for 7 days SHAMANOUSHADI Pathyadi kashaya – 48 ml (20 ml kashaya with approximate 30ml luke warm water) in two divided doses

Inclusion Criteria

Age From	20.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1. Subjects between 20-45 years of age irrespective of sex and willing to participate and provide consent will be included. 2. Subjects having minimum of one episode of headache in 7 days 3. Subjects with clinical features of Ardhavabhedaka (migraine) 4. Subjects attending OPD during Vegavastha of Ardhavabhedaka (Pain Phase of Migraine) 5. Subjects indicated for Rakthamokshana as per classics

ExclusionCriteria

Details

1. Subjects with other primary headache like tension, cluster headache
2. Subjects associated with secondary headache due to Glaucoma, Frontal sinusitis.
3. Subjects with systemic disorders that interfere the course of treatment (Diabetes Mellitus,
Hypertension)
4. Pregnant and lactating women

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Duration of Pain Severity of pain Frequency of attack Nausea Vomiting Tenderness over the scalp Effect on concentration	Day 0 Day 1 Day 15 Day 30

Secondary Outcome

Outcome	TimePoints
Photophobia Phonophobia Headache Impact Test 6 (HIT-6)	Day 0 Day 1 Day 15 Day 30

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 2/ Phase 3

Date of First Enrollment (India)

19/01/2026

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="2"
Months="0"
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

This study is a randomized open label double arm controlled clinical trial to evaluate the efficacy of Viddhakarma and Pathyadi Kashaya tablets in the management of Ardhavabhedaka Migraine. Forty participants aged 20 to 45 years will be randomly assigned into two groups. Group A will receive Viddhakarma with Pathyadi Kashaya decoction and Group B will receive Viddhakarma with Pathyadi Kashaya tablets. The treatment duration is 30 days with assessments at baseline, day 1, day 15 and day 30. Primary outcomes include duration severity and frequency of pain along with associated symptoms such as nausea vomiting and tenderness. Secondary outcomes include photophobia phonophobia and HIT 6 scores. The study aims to establish whether Pathyadi Kashaya tablets provide effective safe and convenient management of migraine compared to the traditional decoction form.