Pathyadi Kwatha in Ardhavabhedaka (episodic migraine)
A randomised, parallel-group clinical trial of Pathyadi Kwatha versus Shirashoolari Vati in Ardhavabhedaka (episodic migraine without aura)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. V. Nambiar · Assistant Professor, Shalakya Tantra
- Condition studied
- Episodic migraine (Ardhavabhedaka)
- Design
- Randomised, parallel group, open label
- Intervention
- Pathyadi Kwatha 40 ml twice daily, 10 weeks
- Comparator
- Shirashoolari Vati 250 mg twice daily
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
29 Apr 2026
EC Approval
19 May 2026
CTRI Registration
08 Jun 2026
Site Activation
28 Jun 2026
Screening
18 Jul 2026
currentEnrolment
—
Follow-up
—
Close-out
—
Enrolment against target
3 of 12 participants (25%)
Screening funnel
Screened through to follow-up completion
Site-wise enrolment
Real institutes from the NPvCC network
| Site | Tier | HFR id | Enrolled | Share |
|---|---|---|---|---|
| All India Institute of Ayurveda, New DelhiNew Delhi · Ayurveda | NPvCC | IN0710000123 | 2 | |
| National Institute of Unani MedicineBengaluru · Unani | IPvC | IN2910000552 | 1 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
3
Current consent version
v1.0
Re-consent required
0
Withdrawn
0
Protocol deviations
2 open of 2 recorded
Assessment
Baseline lipid profile drawn after first dose rather than before
DEV-ARD-01 · 19 Aug 2026
Documentation
Source note for Visit 3 filed without investigator counter-signature
DEV-ARD-02 · 15 Jul 2026
Data queries
1 open · 0 answered · 3 closed
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-ARD-BLR-003
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-ARD-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-ARD-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-ARD-DEL-002
Enrolled participants
De-identified by construction — identifier, sex and age only. No name, address or contact data exists in this system.
| USUBJID | Site | Status | Sex | Age | Planned arm | Consent (RFICDTC) | Ref. start (RFSTDTC) | Visits |
|---|---|---|---|---|---|---|---|---|
| AIIA-ARD-DEL-001 | DEL | on-study-intervention | M | 43 | Comparator arm | 2026-04-05 | 2026-04-10 | 6/8 |
| AIIA-ARD-DEL-002 | DEL | follow-up | F | 49 | Interventional arm | 2026-06-24 | 2026-06-25 | 3/8 |
| AIIA-ARD-BLR-003 | BLR | on-study-intervention | F | 52 | Comparator arm | 2026-04-01 | 2026-04-07 | 1/8 |
1 adverse event recorded on this study — open in Pharmacovigilance