Efficacy of Ashwagandha Ghrita in Sandhivata (osteoarthritis of the knee)
A randomised, parallel-group, open-label comparative clinical trial of Ashwagandha Ghrita versus standard Ayurvedic care in Sandhivata (osteoarthritis of the knee joint)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. A. Krishnamurthy · Professor, Kayachikitsa
- Condition studied
- Osteoarthritis of knee (Sandhivata)
- Design
- Randomised, parallel group, open label
- Intervention
- Ashwagandha Ghrita 10 g twice daily, 12 weeks
- Comparator
- Standard Ayurvedic care (Rasnasaptaka Kwatha)
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
06 Mar 2025
EC Approval
25 Apr 2025
CTRI Registration
14 Jun 2025
Site Activation
03 Aug 2025
Screening
22 Sept 2025
Enrolment
11 Nov 2025
currentFollow-up
—
Close-out
—
Enrolment against target
38 of 40 participants (95%)
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 | 19 | |
| National Institute of AyurvedaJaipur · Ayurveda | IPvC | IN0810000241 | 19 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
38
Current consent version
v2.1
Re-consent required
3
Withdrawn
1
3 participants consented on an earlier version and must be re-consented against v2.1 before their next visit.
Protocol deviations
0 open of 4 recorded
Procedure
Shodhana procedure sequence altered on clinical grounds, not pre-documented
DEV-SAN-01 · 23 Apr 2026
Randomisation
Allocation envelope opened out of sequence at satellite site
DEV-SAN-02 · 23 Jul 2026
Randomisation
Allocation envelope opened out of sequence at satellite site
DEV-SAN-03 · 25 May 2026
Eligibility
Participant enrolled with HbA1c 0.2% above the inclusion ceiling
DEV-SAN-04 · 30 Jun 2026
Data queries
7 open · 4 answered · 38 closed
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-SAN-DEL-027
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-DEL-001
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-JAI-023
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-DEL-012
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-JAI-014
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-JAI-030
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-JAI-036
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-JAI-028
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-008
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-JAI-008
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-JAI-024
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-002
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-JAI-011
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-DEL-006
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-DEL-026
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-013
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-DEL-025
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-JAI-024
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-SAN-JAI-023
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-DEL-037
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-DEL-026
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-SAN-DEL-005
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-023
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-028
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-SAN-DEL-037
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-SAN-JAI-038
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-DEL-027
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-024
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-DEL-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-DEL-025
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-024
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-JAI-031
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-DEL-006
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-DEL-026
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-DEL-015
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-013
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-002
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-SAN-DEL-019
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-SAN-DEL-003
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-SAN-JAI-024
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-034
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-SAN-DEL-019
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-SAN-DEL-007
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-023
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-SAN-JAI-033
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-SAN-JAI-034
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-SAN-JAI-029
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-SAN-DEL-001 | DEL | on-study-intervention | F | 66 | Comparator arm | 2026-06-14 | 2026-06-20 | 2/8 |
| AIIA-SAN-JAI-002 | JAI | on-study-intervention | M | 32 | Interventional arm | 2026-06-12 | 2026-06-18 | 2/8 |
| AIIA-SAN-DEL-003 | DEL | on-study | F | 24 | Comparator arm | 2026-04-05 | 2026-04-10 | 6/8 |
| AIIA-SAN-DEL-004 | DEL | withdrawn | F | 47 | Interventional arm | 2026-04-19 | 2026-04-22 | 1/8 |
| AIIA-SAN-DEL-005 | DEL | on-study | F | 63 | Comparator arm | 2026-05-11 | 2026-05-14 | 8/8 |
| AIIA-SAN-DEL-006 | DEL | on-study-intervention | F | 38 | Interventional arm | 2026-05-29 | 2026-05-31 | 6/8 |
| AIIA-SAN-DEL-007 | DEL | on-study | M | 64 | Comparator arm | 2026-07-10 | 2026-07-12 | 7/8 |
| AIIA-SAN-JAI-008 | JAI | on-study | F | 26 | Interventional arm | 2026-05-29 | 2026-05-31 | 3/8 |
| AIIA-SAN-JAI-009 | JAI | withdrawn | F | 58 | Comparator arm | 2026-04-02 | 2026-04-07 | 6/8 |
| AIIA-SAN-DEL-010 | DEL | on-study-intervention | F | 58 | Interventional arm | 2026-05-04 | 2026-05-07 | 3/8 |
| AIIA-SAN-JAI-011 | JAI | on-study-intervention | M | 54 | Comparator arm | 2026-05-02 | 2026-05-03 | 3/8 |
| AIIA-SAN-DEL-012 | DEL | on-study | F | 24 | Interventional arm | 2026-03-10 | 2026-03-14 | 8/8 |
| AIIA-SAN-JAI-013 | JAI | on-study-intervention | M | 46 | Comparator arm | 2026-05-14 | 2026-05-15 | 3/8 |
| AIIA-SAN-JAI-014 | JAI | on-study-intervention | F | 51 | Interventional arm | 2026-03-14 | 2026-03-15 | 8/8 |
| AIIA-SAN-DEL-015 | DEL | follow-up | M | 28 | Comparator arm | 2026-06-02 | 2026-06-03 | 4/8 |
| AIIA-SAN-DEL-016 | DEL | follow-up | F | 66 | Interventional arm | 2026-03-17 | 2026-03-22 | 1/8 |
| AIIA-SAN-DEL-017 | DEL | on-study-intervention | M | 54 | Comparator arm | 2026-04-24 | 2026-04-25 | 7/8 |
| AIIA-SAN-DEL-018 | DEL | on-study-intervention | M | 31 | Interventional arm | 2026-05-02 | 2026-05-04 | 8/8 |
| AIIA-SAN-DEL-019 | DEL | on-study-intervention | M | 44 | Comparator arm | 2026-07-06 | 2026-07-07 | 3/8 |
| AIIA-SAN-JAI-020 | JAI | withdrawn | F | 49 | Interventional arm | 2026-04-12 | 2026-04-14 | 5/8 |
| AIIA-SAN-DEL-021 | DEL | on-study-intervention | M | 61 | Comparator arm | 2026-06-21 | 2026-06-23 | 7/8 |
| AIIA-SAN-JAI-022 | JAI | on-study | M | 24 | Interventional arm | 2026-07-09 | 2026-07-13 | 4/8 |
| AIIA-SAN-JAI-023 | JAI | follow-up | F | 53 | Comparator arm | 2026-07-11 | 2026-07-15 | 8/8 |
| AIIA-SAN-JAI-024 | JAI | on-study | M | 41 | Interventional arm | 2026-04-10 | 2026-04-13 | 5/8 |
| AIIA-SAN-DEL-025 | DEL | withdrawn | M | 63 | Comparator arm | 2026-03-10 | 2026-03-13 | 5/8 |
| AIIA-SAN-DEL-026 | DEL | on-study | F | 65 | Interventional arm | 2026-05-08 | 2026-05-11 | 4/8 |
| AIIA-SAN-DEL-027 | DEL | on-study-intervention | M | 64 | Comparator arm | 2026-08-03 | 2026-08-05 | 7/8 |
| AIIA-SAN-JAI-028 | JAI | follow-up | M | 66 | Interventional arm | 2026-05-30 | 2026-06-05 | 7/8 |
| AIIA-SAN-JAI-029 | JAI | on-study-intervention | F | 34 | Comparator arm | 2026-07-02 | 2026-07-07 | 3/8 |
| AIIA-SAN-JAI-030 | JAI | on-study-intervention | F | 42 | Interventional arm | 2026-05-23 | 2026-05-27 | 1/8 |
| AIIA-SAN-JAI-031 | JAI | follow-up | F | 60 | Comparator arm | 2026-04-30 | 2026-05-01 | 5/8 |
| AIIA-SAN-DEL-032 | DEL | withdrawn | F | 26 | Interventional arm | 2026-03-11 | 2026-03-15 | 4/8 |
| AIIA-SAN-JAI-033 | JAI | on-study | F | 63 | Comparator arm | 2026-06-25 | 2026-06-26 | 2/8 |
| AIIA-SAN-JAI-034 | JAI | follow-up | F | 65 | Interventional arm | 2026-05-11 | 2026-05-16 | 2/8 |
| AIIA-SAN-JAI-035 | JAI | on-study-intervention | M | 36 | Comparator arm | 2026-04-13 | 2026-04-19 | 5/8 |
| AIIA-SAN-JAI-036 | JAI | on-study | M | 64 | Interventional arm | 2026-04-15 | 2026-04-18 | 5/8 |
| AIIA-SAN-DEL-037 | DEL | on-study | F | 50 | Comparator arm | 2026-03-27 | 2026-04-02 | 5/8 |
| AIIA-SAN-JAI-038 | JAI | on-study-intervention | M | 35 | Interventional arm | 2026-08-24 | 2026-08-30 | 4/8 |
10 adverse events recorded on this study · 1 serious — open in Pharmacovigilance