Kutajarishta in Grahani Roga (diarrhoea-predominant irritable bowel syndrome)
An open-label, single-arm interventional study of Kutajarishta in the management of Grahani Roga with reference to diarrhoea-predominant irritable bowel syndrome
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. M. Rathore · Associate Professor, Kayachikitsa
- Condition studied
- Irritable bowel syndrome, diarrhoea-predominant (Grahani Roga)
- Design
- Single arm, open label
- Intervention
- Kutajarishta 20 ml twice daily after meals, 8 weeks
- Comparator
- Single arm — no comparator
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
05 Oct 2025
EC Approval
04 Nov 2025
CTRI Registration
05 Dec 2025
Site Activation
05 Jan 2026
Screening
04 Feb 2026
Enrolment
07 Mar 2026
currentFollow-up
—
Close-out
—
Enrolment against target
17 of 24 participants (71%)
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 | 17 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
17
Current consent version
v1.2
Re-consent required
0
Withdrawn
1
Protocol deviations
3 open of 3 recorded
Procedure
Shodhana procedure sequence altered on clinical grounds, not pre-documented
DEV-GRH-01 · 18 Jul 2026
Consent process
Consent form signed but date of signature not recorded by witness
DEV-GRH-02 · 10 Apr 2026
Study drug
Dispensing log not reconciled at end of month
DEV-GRH-03 · 26 Jun 2026
Data queries
3 open · 2 answered · 19 closed
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-GRH-DEL-013
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-GRH-DEL-017
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-GRH-DEL-017
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-GRH-DEL-002
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-GRH-DEL-004
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-GRH-DEL-010
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-GRH-DEL-002
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-GRH-DEL-004
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-GRH-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-GRH-DEL-002
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-GRH-DEL-014
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-GRH-DEL-008
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-GRH-DEL-006
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-GRH-DEL-011
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-GRH-DEL-007
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-GRH-DEL-014
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-GRH-DEL-011
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-GRH-DEL-016
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-GRH-DEL-003
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-GRH-DEL-007
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-GRH-DEL-015
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-GRH-DEL-004
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-GRH-DEL-005
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-GRH-DEL-011
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-GRH-DEL-001 | DEL | follow-up | M | 36 | Interventional arm | 2026-05-28 | 2026-06-01 | 8/8 |
| AIIA-GRH-DEL-002 | DEL | on-study | M | 56 | Interventional arm | 2026-05-21 | 2026-05-22 | 6/8 |
| AIIA-GRH-DEL-003 | DEL | on-study-intervention | F | 41 | Interventional arm | 2026-08-24 | 2026-08-25 | 3/8 |
| AIIA-GRH-DEL-004 | DEL | on-study-intervention | M | 59 | Interventional arm | 2026-04-20 | 2026-04-26 | 7/8 |
| AIIA-GRH-DEL-005 | DEL | on-study-intervention | M | 40 | Interventional arm | 2026-08-06 | 2026-08-07 | 6/8 |
| AIIA-GRH-DEL-006 | DEL | on-study | F | 37 | Interventional arm | 2026-05-19 | 2026-05-24 | 1/8 |
| AIIA-GRH-DEL-007 | DEL | on-study | M | 30 | Interventional arm | 2026-05-15 | 2026-05-16 | 3/8 |
| AIIA-GRH-DEL-008 | DEL | on-study | M | 63 | Interventional arm | 2026-03-16 | 2026-03-18 | 7/8 |
| AIIA-GRH-DEL-009 | DEL | follow-up | M | 37 | Interventional arm | 2026-08-20 | 2026-08-21 | 4/8 |
| AIIA-GRH-DEL-010 | DEL | on-study | M | 37 | Interventional arm | 2026-06-16 | 2026-06-22 | 6/8 |
| AIIA-GRH-DEL-011 | DEL | on-study-intervention | M | 42 | Interventional arm | 2026-05-09 | 2026-05-13 | 7/8 |
| AIIA-GRH-DEL-012 | DEL | on-study-intervention | M | 62 | Interventional arm | 2026-07-04 | 2026-07-08 | 5/8 |
| AIIA-GRH-DEL-013 | DEL | on-study-intervention | F | 50 | Interventional arm | 2026-04-02 | 2026-04-07 | 2/8 |
| AIIA-GRH-DEL-014 | DEL | on-study-intervention | F | 63 | Interventional arm | 2026-05-19 | 2026-05-21 | 3/8 |
| AIIA-GRH-DEL-015 | DEL | on-study | M | 59 | Interventional arm | 2026-08-09 | 2026-08-15 | 6/8 |
| AIIA-GRH-DEL-016 | DEL | on-study-intervention | M | 52 | Interventional arm | 2026-03-15 | 2026-03-16 | 5/8 |
| AIIA-GRH-DEL-017 | DEL | on-study-intervention | M | 48 | Interventional arm | 2026-08-20 | 2026-08-21 | 7/8 |
9 adverse events recorded on this study · 1 serious — open in Pharmacovigilance