Brahmi Vati and Shirodhara in Chittodvega (generalised anxiety disorder)
A randomised, parallel-group study of Brahmi Vati with Shirodhara versus Brahmi Vati alone in Chittodvega (generalised anxiety disorder)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. K. Menon · Assistant Professor, Manas Roga
- Condition studied
- Generalised anxiety disorder (Chittodvega)
- Design
- Randomised, parallel group, open label
- Intervention
- Brahmi Vati 500 mg twice daily + Shirodhara, 8 weeks
- Comparator
- Brahmi Vati 500 mg twice daily
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
13 Feb 2026
EC Approval
05 Mar 2026
CTRI Registration
25 Mar 2026
Site Activation
14 Apr 2026
Screening
04 May 2026
Enrolment
24 May 2026
currentFollow-up
—
Close-out
—
Enrolment against target
6 of 16 participants (38%)
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 | 6 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
6
Current consent version
v1.0
Re-consent required
0
Withdrawn
0
Protocol deviations
1 open of 2 recorded
Visit window
Week-8 assessment performed 6 days outside the protocol window
DEV-CHT-01 · 16 May 2026
Procedure
Shodhana procedure sequence altered on clinical grounds, not pre-documented
DEV-CHT-02 · 26 Aug 2026
Data queries
4 open · 1 answered · 8 closed
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-CHT-DEL-005
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-CHT-DEL-006
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-CHT-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-CHT-DEL-003
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-CHT-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-CHT-DEL-004
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-CHT-DEL-003
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-CHT-DEL-005
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-CHT-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-CHT-DEL-006
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-CHT-DEL-003
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-CHT-DEL-005
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-CHT-DEL-006
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-CHT-DEL-001 | DEL | on-study | M | 49 | Comparator arm | 2026-06-16 | 2026-06-20 | 8/8 |
| AIIA-CHT-DEL-002 | DEL | on-study | M | 48 | Interventional arm | 2026-03-15 | 2026-03-21 | 4/8 |
| AIIA-CHT-DEL-003 | DEL | on-study-intervention | M | 30 | Comparator arm | 2026-08-23 | 2026-08-24 | 1/8 |
| AIIA-CHT-DEL-004 | DEL | on-study | M | 33 | Interventional arm | 2026-04-03 | 2026-04-05 | 4/8 |
| AIIA-CHT-DEL-005 | DEL | on-study-intervention | M | 33 | Comparator arm | 2026-05-08 | 2026-05-12 | 3/8 |
| AIIA-CHT-DEL-006 | DEL | follow-up | F | 30 | Interventional arm | 2026-03-29 | 2026-03-30 | 5/8 |
3 adverse events recorded on this study — open in Pharmacovigilance