Simhanada Guggulu with Shodhana in Amavata (rheumatoid arthritis)
A randomised comparative clinical study of Simhanada Guggulu preceded by Virechana Shodhana versus Simhanada Guggulu alone in Amavata (rheumatoid arthritis)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. R. Bhattacharya · Professor, Panchakarma
- Condition studied
- Rheumatoid arthritis (Amavata)
- Design
- Randomised, parallel group, open label
- Intervention
- Virechana Shodhana followed by Simhanada Guggulu, 16 weeks
- Comparator
- Simhanada Guggulu alone
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
14 Nov 2025
EC Approval
11 Dec 2025
CTRI Registration
07 Jan 2026
Site Activation
03 Feb 2026
Screening
02 Mar 2026
Enrolment
29 Mar 2026
currentFollow-up
—
Close-out
—
Enrolment against target
8 of 18 participants (44%)
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 | 5 | |
| Institute of Teaching and Research in Ayurveda (ITRA)Jamnagar · Ayurveda | IPvC | IN2410000318 | 3 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
8
Current consent version
v2.0
Re-consent required
1
Withdrawn
0
1 participant consented on an earlier version and must be re-consented against v2.0 before their next visit.
Protocol deviations
1 open of 1 recorded
Randomisation
Allocation envelope opened out of sequence at satellite site
DEV-AMV-01 · 09 Aug 2026
Data queries
5 open · 1 answered · 14 closed
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-AMV-DEL-007
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-AMV-DEL-001
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-AMV-JAM-006
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-AMV-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-AMV-DEL-004
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-AMV-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-AMV-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-AMV-JAM-003
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-AMV-DEL-008
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-AMV-DEL-004
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-AMV-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-AMV-DEL-008
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-AMV-DEL-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-AMV-JAM-003
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-AMV-JAM-006
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-AMV-DEL-004
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-AMV-JAM-003
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-AMV-DEL-008
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-AMV-JAM-003
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-AMV-DEL-008
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-AMV-DEL-001 | DEL | on-study-intervention | F | 36 | Comparator arm | 2026-05-10 | 2026-05-12 | 6/8 |
| AIIA-AMV-DEL-002 | DEL | on-study-intervention | F | 28 | Interventional arm | 2026-05-16 | 2026-05-21 | 8/8 |
| AIIA-AMV-JAM-003 | JAM | on-study-intervention | F | 65 | Comparator arm | 2026-06-30 | 2026-07-01 | 2/8 |
| AIIA-AMV-DEL-004 | DEL | on-study-intervention | F | 26 | Interventional arm | 2026-06-22 | 2026-06-27 | 4/8 |
| AIIA-AMV-JAM-005 | JAM | on-study | M | 67 | Comparator arm | 2026-05-15 | 2026-05-19 | 1/8 |
| AIIA-AMV-JAM-006 | JAM | on-study | M | 68 | Interventional arm | 2026-06-21 | 2026-06-26 | 3/8 |
| AIIA-AMV-DEL-007 | DEL | follow-up | F | 43 | Comparator arm | 2026-03-13 | 2026-03-17 | 2/8 |
| AIIA-AMV-DEL-008 | DEL | on-study-intervention | F | 63 | Interventional arm | 2026-08-23 | 2026-08-27 | 1/8 |
3 adverse events recorded on this study · 1 serious — open in Pharmacovigilance