Varunadi Kwatha in Mutraghata (benign prostatic hyperplasia)
A randomised controlled trial of Varunadi Kwatha with Gokshuradi Guggulu versus Gokshuradi Guggulu alone in Mutraghata (benign prostatic hyperplasia, IPSS 8–19)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. B. Sengupta · Professor, Shalya Tantra
- Condition studied
- Benign prostatic hyperplasia (Mutraghata)
- Design
- Randomised, parallel group, open label
- Intervention
- Varunadi Kwatha 40 ml twice daily + Gokshuradi Guggulu, 12 weeks
- Comparator
- Gokshuradi Guggulu alone
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
07 Aug 2024
EC Approval
04 Oct 2024
CTRI Registration
02 Dec 2024
Site Activation
29 Jan 2025
Screening
29 Mar 2025
Enrolment
26 May 2025
Follow-up
24 Jul 2025
currentClose-out
—
Enrolment against target
1 of 26 participants (4%)
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 | 1 | |
| National Institute of SiddhaChennai · Siddha | IPvC | IN3310000407 | 0 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
1
Current consent version
v2.2
Re-consent required
1
Withdrawn
0
1 participant consented on an earlier version and must be re-consented against v2.2 before their next visit.
Protocol deviations
0 open of 0 recorded
No deviations recorded.
Data queries
1 open · 1 answered · 24 closed
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MUT-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MUT-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MUT-DEL-001
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MUT-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MUT-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MUT-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MUT-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MUT-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MUT-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MUT-DEL-001
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MUT-DEL-001
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MUT-DEL-001
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MUT-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MUT-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MUT-DEL-001
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MUT-DEL-001
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MUT-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MUT-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MUT-DEL-001
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MUT-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MUT-DEL-001
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MUT-DEL-001
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MUT-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MUT-DEL-001
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MUT-DEL-001
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MUT-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-MUT-DEL-001 | DEL | withdrawn | M | 50 | Comparator arm | 2026-05-19 | 2026-05-24 | 1/8 |