Arogyavardhini Vati in non-alcoholic fatty liver disease (Yakrit Vikara)
A randomised controlled trial of Arogyavardhini Vati with dietary regulation in grade I–II non-alcoholic fatty liver disease
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. T. Subramanian · Professor, Kayachikitsa
- Condition studied
- Non-alcoholic fatty liver disease (Yakrit Vikara)
- Design
- Randomised, parallel group, open label
- Intervention
- Arogyavardhini Vati 500 mg twice daily + Pathya, 16 weeks
- Comparator
- Dietary regulation alone
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
26 Jan 2026
EC Approval
16 Feb 2026
CTRI Registration
08 Mar 2026
Site Activation
28 Mar 2026
Screening
18 Apr 2026
Enrolment
08 May 2026
currentFollow-up
—
Close-out
—
Enrolment against target
7 of 22 participants (32%)
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 | 4 | |
| National Institute of AyurvedaJaipur · Ayurveda | IPvC | IN0810000241 | 0 | |
| National Institute of SiddhaChennai · Siddha | IPvC | IN3310000407 | 3 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
7
Current consent version
v1.2
Re-consent required
0
Withdrawn
1
Protocol deviations
0 open of 0 recorded
No deviations recorded.
Data queries
9 open · 5 answered · 11 closed
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-YAK-DEL-002
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-YAK-CHE-007
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-YAK-CHE-007
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-YAK-DEL-005
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-YAK-DEL-004
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-CHE-006
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-YAK-DEL-005
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-YAK-CHE-007
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-YAK-DEL-004
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-YAK-DEL-004
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-DEL-002
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-YAK-CHE-007
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-CHE-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-YAK-CHE-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-DEL-003
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-YAK-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-YAK-DEL-003
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-CHE-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-YAK-CHE-006
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-YAK-CHE-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-YAK-CHE-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-YAK-CHE-006
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-YAK-CHE-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-YAK-DEL-003
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-YAK-CHE-001
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-YAK-CHE-001 | CHE | withdrawn | F | 66 | Comparator arm | 2026-05-03 | 2026-05-04 | 5/8 |
| AIIA-YAK-DEL-002 | DEL | on-study-intervention | F | 66 | Interventional arm | 2026-08-23 | 2026-08-24 | 4/8 |
| AIIA-YAK-DEL-003 | DEL | on-study-intervention | F | 33 | Comparator arm | 2026-03-08 | 2026-03-12 | 2/8 |
| AIIA-YAK-DEL-004 | DEL | on-study-intervention | M | 54 | Interventional arm | 2026-08-28 | 2026-09-01 | 5/8 |
| AIIA-YAK-DEL-005 | DEL | on-study-intervention | F | 26 | Comparator arm | 2026-04-07 | 2026-04-12 | 6/8 |
| AIIA-YAK-CHE-006 | CHE | on-study-intervention | M | 65 | Interventional arm | 2026-05-28 | 2026-05-29 | 5/8 |
| AIIA-YAK-CHE-007 | CHE | on-study-intervention | F | 46 | Comparator arm | 2026-05-15 | 2026-05-18 | 3/8 |
2 adverse events recorded on this study · 1 serious — open in Pharmacovigilance