Vasavaleha as add-on therapy in Tamaka Shwasa (mild persistent bronchial asthma)
A randomised, double-blind, placebo-controlled trial of Vasavaleha as add-on to standard care in Tamaka Shwasa (mild persistent bronchial asthma)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. P. Iyengar · Professor, Kaumarabhritya
- Condition studied
- Bronchial asthma, mild persistent (Tamaka Shwasa)
- Design
- Randomised, double blind, placebo controlled
- Intervention
- Vasavaleha 10 g twice daily as add-on, 12 weeks
- Comparator
- Matched placebo add-on
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
24 Dec 2025
EC Approval
17 Jan 2026
CTRI Registration
09 Feb 2026
Site Activation
04 Mar 2026
Screening
28 Mar 2026
Enrolment
20 Apr 2026
currentFollow-up
—
Close-out
—
Enrolment against target
9 of 30 participants (30%)
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 | 7 | |
| National Institute of Unani MedicineBengaluru · Unani | IPvC | IN2910000552 | 2 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
9
Current consent version
v1.1
Re-consent required
2
Withdrawn
1
2 participants consented on an earlier version and must be re-consented against v1.1 before their next visit.
Protocol deviations
2 open of 2 recorded
Eligibility
Participant enrolled with HbA1c 0.2% above the inclusion ceiling
DEV-TAM-01 · 02 Aug 2026
Assessment
Baseline lipid profile drawn after first dose rather than before
DEV-TAM-02 · 11 Jun 2026
Data queries
11 open · 3 answered · 9 closed
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-TAM-DEL-008
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-TAM-DEL-008
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-TAM-DEL-007
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-TAM-DEL-002
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-TAM-DEL-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-TAM-DEL-005
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-TAM-DEL-005
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-TAM-DEL-005
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-TAM-DEL-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-TAM-BLR-009
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-TAM-DEL-004
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-TAM-DEL-007
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-TAM-DEL-005
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-TAM-DEL-002
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-TAM-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-TAM-DEL-002
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-TAM-DEL-002
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-TAM-DEL-005
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-TAM-BLR-009
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-TAM-DEL-004
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-TAM-BLR-006
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-TAM-DEL-001
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-TAM-DEL-004
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-TAM-DEL-001 | DEL | follow-up | F | 43 | Comparator arm | 2026-08-17 | 2026-08-18 | 4/8 |
| AIIA-TAM-DEL-002 | DEL | on-study | M | 67 | Interventional arm | 2026-05-11 | 2026-05-16 | 1/8 |
| AIIA-TAM-DEL-003 | DEL | withdrawn | F | 68 | Comparator arm | 2026-04-13 | 2026-04-18 | 7/8 |
| AIIA-TAM-DEL-004 | DEL | follow-up | M | 43 | Interventional arm | 2026-07-08 | 2026-07-11 | 2/8 |
| AIIA-TAM-DEL-005 | DEL | on-study | F | 27 | Comparator arm | 2026-04-06 | 2026-04-11 | 3/8 |
| AIIA-TAM-BLR-006 | BLR | on-study | M | 28 | Interventional arm | 2026-04-25 | 2026-04-28 | 6/8 |
| AIIA-TAM-DEL-007 | DEL | on-study-intervention | F | 67 | Comparator arm | 2026-04-19 | 2026-04-23 | 6/8 |
| AIIA-TAM-DEL-008 | DEL | on-study | M | 38 | Interventional arm | 2026-08-11 | 2026-08-12 | 6/8 |
| AIIA-TAM-BLR-009 | BLR | on-study | M | 41 | Comparator arm | 2026-04-07 | 2026-04-13 | 3/8 |
3 adverse events recorded on this study · 1 serious — open in Pharmacovigilance