Guduchi and Ashwagandha in chemotherapy-induced fatigue
An open-label pilot study of a Guduchi–Ashwagandha combination as supportive care for chemotherapy-induced fatigue in solid tumour patients
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. L. Chandrasekhar · Associate Professor, Integrative Oncology
- Condition studied
- Chemotherapy-induced fatigue
- Design
- Single arm, open label pilot
- Intervention
- Guduchi 500 mg + Ashwagandha 500 mg twice daily, 8 weeks
- Comparator
- Single arm — no comparator
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
15 Mar 2026
EC Approval
04 Apr 2026
CTRI Registration
24 Apr 2026
Site Activation
14 May 2026
Screening
03 Jun 2026
Enrolment
23 Jun 2026
currentFollow-up
—
Close-out
—
Enrolment against target
5 of 15 participants (33%)
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 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
5
Current consent version
v1.1
Re-consent required
0
Withdrawn
0
Protocol deviations
1 open of 2 recorded
Study drug
Dispensing log not reconciled at end of month
DEV-ONC-01 · 02 Jun 2026
Randomisation
Allocation envelope opened out of sequence at satellite site
DEV-ONC-02 · 01 Sept 2026
Data queries
2 open · 2 answered · 6 closed
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-ONC-DEL-002
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-ONC-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-ONC-DEL-002
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-ONC-DEL-002
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-ONC-DEL-003
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-ONC-DEL-003
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-ONC-DEL-005
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-ONC-DEL-004
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-ONC-DEL-003
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-ONC-DEL-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-ONC-DEL-001 | DEL | on-study-intervention | F | 33 | Interventional arm | 2026-06-25 | 2026-06-28 | 7/8 |
| AIIA-ONC-DEL-002 | DEL | on-study | F | 40 | Interventional arm | 2026-04-25 | 2026-04-29 | 4/8 |
| AIIA-ONC-DEL-003 | DEL | on-study | F | 41 | Interventional arm | 2026-03-07 | 2026-03-13 | 7/8 |
| AIIA-ONC-DEL-004 | DEL | withdrawn | F | 29 | Interventional arm | 2026-03-21 | 2026-03-27 | 7/8 |
| AIIA-ONC-DEL-005 | DEL | on-study-intervention | F | 25 | Interventional arm | 2026-03-14 | 2026-03-17 | 1/8 |
2 adverse events recorded on this study — open in Pharmacovigilance