SYNTHETIC DEMO DATA — no real patient information

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CTRI/2026/XX/SYN011SyntheticActivePhase 2Metabolic & Endocrine

Medohar Guggulu in Medoroga (dyslipidaemia with central obesity)

A randomised controlled trial of Medohar Guggulu with Udvartana versus lifestyle modification in Medoroga presenting as dyslipidaemia with central obesity

Sponsor
All India Institute of Ayurveda (intramural)
Principal investigator
Dr. G. Pillai · Associate Professor, Swasthavritta
Condition studied
Dyslipidaemia with central obesity (Medoroga)
Design
Randomised, parallel group, open label
Intervention
Medohar Guggulu 1 g twice daily + Udvartana, 20 weeks
Comparator
Structured lifestyle modification

Study lifecycle

Protocol through close-out. Completed stages are filled, the current stage pulses.

Protocol

06 Jun 2026

EC Approval

26 Jun 2026

CTRI Registration

16 Jul 2026

4

Site Activation

05 Aug 2026

current
5

Screening

—

6

Enrolment

—

7

Follow-up

—

8

Close-out

—

Enrolment against target

2 of 20 participants (10%)

Enrolment lag

Screening funnel

Screened through to follow-up completion

Site-wise enrolment

Real institutes from the NPvCC network

SiteTierHFR idEnrolledShare
All India Institute of Ayurveda, New DelhiNew Delhi · AyurvedaNPvCCIN07100001232
Institute of Teaching and Research in Ayurveda (ITRA)Jamnagar · AyurvedaIPvCIN24100003180

Consent tracking

Versioned, specific and withdrawable — the DPDP requirement

Participants consented

2

Current consent version

v1.0

Re-consent required

0

Withdrawn

0

Protocol deviations

2 open of 2 recorded

Randomisation

Allocation envelope opened out of sequence at satellite site

DEV-MED-01 · 10 Aug 2026

MajorCAPA raised

Study drug

Dispensing log not reconciled at end of month

DEV-MED-02 · 03 May 2026

MajorCAPA raised

Data queries

0 open · 0 answered · 1 closed

Birth date inconsistent with the age recorded at screening — please confirm.

Demographics · BRTHDTC · AIIA-MED-DEL-001

Closed89d

Enrolled participants

De-identified by construction — identifier, sex and age only. No name, address or contact data exists in this system.

2 participants
USUBJIDSiteStatusSexAgePlanned armConsent (RFICDTC)Ref. start (RFSTDTC)Visits
AIIA-MED-DEL-001DELon-study-interventionF44Comparator arm2026-06-062026-06-103/8
AIIA-MED-DEL-002DELwithdrawnM30Interventional arm2026-06-072026-06-118/8

1 adverse event recorded on this study — open in Pharmacovigilance