Nishamalaki and lifestyle intervention in Madhumeha (type 2 diabetes mellitus)
A randomised controlled trial evaluating Nishamalaki Churna with structured Pathya-Apathya counselling versus counselling alone in early type 2 diabetes mellitus (Madhumeha)
- Sponsor
- All India Institute of Ayurveda (intramural)
- Principal investigator
- Dr. S. Venkatesan · Additional Professor, Kayachikitsa
- Condition studied
- Type 2 diabetes mellitus (Madhumeha)
- Design
- Randomised, parallel group, assessor blinded
- Intervention
- Nishamalaki Churna 3 g twice daily + Pathya counselling, 24 weeks
- Comparator
- Pathya-Apathya counselling alone
Study lifecycle
Protocol through close-out. Completed stages are filled, the current stage pulses.
Protocol
16 Jul 2025
EC Approval
23 Aug 2025
CTRI Registration
30 Sept 2025
Site Activation
07 Nov 2025
Screening
15 Dec 2025
Enrolment
22 Jan 2026
currentFollow-up
—
Close-out
—
Enrolment against target
12 of 40 participants (30%)
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 | 6 | |
| Institute of Teaching and Research in Ayurveda (ITRA)Jamnagar · Ayurveda | IPvC | IN2410000318 | 2 | |
| National Institute of AyurvedaJaipur · Ayurveda | IPvC | IN0810000241 | 4 |
Consent tracking
Versioned, specific and withdrawable — the DPDP requirement
Participants consented
12
Current consent version
v1.4
Re-consent required
0
Withdrawn
1
Protocol deviations
0 open of 2 recorded
Documentation
Source note for Visit 3 filed without investigator counter-signature
DEV-MAD-01 · 21 Jun 2026
Procedure
Shodhana procedure sequence altered on clinical grounds, not pre-documented
DEV-MAD-02 · 16 Jul 2026
Data queries
14 open · 6 answered · 21 closed
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-006
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MAD-DEL-001
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-008
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MAD-DEL-007
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MAD-DEL-004
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-007
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MAD-JAI-008
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-MAD-DEL-011
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-DEL-002
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-003
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-JAI-005
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-JAI-010
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MAD-JAI-003
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAM-012
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MAD-DEL-011
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MAD-DEL-002
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MAD-DEL-001
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MAD-JAM-012
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MAD-DEL-001
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MAD-DEL-002
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MAD-JAM-009
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-007
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MAD-DEL-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-010
AE onset date precedes the first dose date. Please verify.
Adverse events · AESTDTC · AIIA-MAD-DEL-007
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-005
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MAD-DEL-004
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-MAD-DEL-011
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-004
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MAD-DEL-006
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-DEL-006
Systolic BP of 210 mm[Hg] not flagged as an AE — clinically significant?
Vital signs · VSORRES (SYSBP) · AIIA-MAD-DEL-001
Hospitalisation noted in the narrative but AESER recorded as N. Please reconcile.
Adverse events · AESER · AIIA-MAD-DEL-006
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-008
Subject marked completed but Visit 6 is missing.
Disposition · DSDECOD · AIIA-MAD-JAI-005
Birth date inconsistent with the age recorded at screening — please confirm.
Demographics · BRTHDTC · AIIA-MAD-DEL-011
Result outside reference range with no interpretation recorded.
Laboratory · LBORRES (SGPT) · AIIA-MAD-JAI-008
Concomitant medicine entered as a brand name — please give the generic.
Concomitant meds · CMTRT · AIIA-MAD-JAI-005
Dose recorded as 0 for Visit 4 with no interruption reason.
Exposure · EXDOSE · AIIA-MAD-JAI-003
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-MAD-DEL-001 | DEL | on-study | F | 65 | Comparator arm | 2026-07-18 | 2026-07-24 | 4/8 |
| AIIA-MAD-DEL-002 | DEL | on-study-intervention | F | 44 | Interventional arm | 2026-06-08 | 2026-06-14 | 3/8 |
| AIIA-MAD-JAI-003 | JAI | on-study-intervention | F | 32 | Comparator arm | 2026-05-23 | 2026-05-24 | 3/8 |
| AIIA-MAD-DEL-004 | DEL | follow-up | M | 31 | Interventional arm | 2026-03-20 | 2026-03-24 | 3/8 |
| AIIA-MAD-JAI-005 | JAI | on-study-intervention | F | 60 | Comparator arm | 2026-08-10 | 2026-08-14 | 8/8 |
| AIIA-MAD-DEL-006 | DEL | on-study-intervention | F | 57 | Interventional arm | 2026-05-25 | 2026-05-30 | 3/8 |
| AIIA-MAD-DEL-007 | DEL | on-study-intervention | M | 41 | Comparator arm | 2026-04-26 | 2026-05-01 | 7/8 |
| AIIA-MAD-JAI-008 | JAI | on-study | M | 54 | Interventional arm | 2026-07-22 | 2026-07-25 | 5/8 |
| AIIA-MAD-JAM-009 | JAM | on-study | M | 31 | Comparator arm | 2026-03-18 | 2026-03-22 | 8/8 |
| AIIA-MAD-JAI-010 | JAI | follow-up | M | 35 | Interventional arm | 2026-06-11 | 2026-06-16 | 7/8 |
| AIIA-MAD-DEL-011 | DEL | follow-up | F | 36 | Comparator arm | 2026-06-28 | 2026-07-03 | 2/8 |
| AIIA-MAD-JAM-012 | JAM | on-study-intervention | M | 24 | Interventional arm | 2026-08-11 | 2026-08-17 | 8/8 |
4 adverse events recorded on this study · 1 serious — open in Pharmacovigilance