SYNTHETIC DEMO DATA — no real patient information

AIAIIA Clinical TrialsAll India Institute of Ayurveda · NPvCC

Pharmacovigilance

The All India Institute of Ayurveda is the National Pharmacovigilance Coordination Centre (NPvCC) for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs. This page covers trial-phase safety: adverse events captured on studies in progress, and their statutory reporting clocks under the New Drugs and Clinical Trials Rules, 2019.

Adverse events recorded

40

all studies, all sites

Serious events (AESER = Y)

7

3 with a live reporting clock

Open events

17

outcome not resolved

Events this quarter

32

onset within 92 days

Advertisements flagged

4

misleading-advertisement surveillance

NPvCC pharmacovigilance network

AIIA is the National Pharmacovigilance Coordination Centre (NPvCC) for the Central Sector Scheme for Pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs, under the Ministry of Ayush and with technical support from the Indian Pharmacopoeia Commission.

3-tier · reports flow upward

Tier 1 — National

All India Institute of Ayurveda, New Delhi

Consolidates all ADR reports · The Coordinator, NPvCC, Sarita Vihar, New Delhi – 110076

279

reports consolidated this quarter

consolidated upward from the intermediary centres

Tier 2 — Intermediary Pharmacovigilance Centres (IPvCs) · 5 National Institutes of Ayush

National Institute of Ayurveda

Jaipur · Ayurveda

47

ADR reports

16

PPvCs

Institute of Teaching and Research in Ayurveda (ITRA)

Jamnagar · Ayurveda

62

ADR reports

20

PPvCs

National Institute of Siddha

Chennai · Siddha

47

ADR reports

18

PPvCs

National Institute of Unani Medicine

Bengaluru · Unani

55

ADR reports

14

PPvCs

National Institute of Homoeopathy

Kolkata · Homoeopathy

68

ADR reports

15

PPvCs

forwarded from the peripheral centres, and received directly from consumers, practitioners and industry

Tier 3 — Peripheral Pharmacovigilance Centres (PPvCs)

Institutions with clinical facilities · 10–20 peripheral centres per IPvC

99

peripheral centres, as reported by AIIA (aiia.gov.in)

Centre counts move as the network grows; AIIA's own page is the authority. Report volumes shown per centre are synthetic. This CTMS contributes the trial-phase layer — post-marketing ADR reporting for marketed ASU&H drugs runs on the Ministry's Ayush Suraksha platform.

NDCT Rules 2019 — SAE reporting clocks

Initial report within 24 hours of occurrence to Sponsor, Ethics Committee and CDSCO / Central Licensing Authority. Detailed analysed report within 14 days to Sponsor, Ethics Committee, Central Licensing Authority. An SAE of death is additionally reported within 14 days of knowledge to DCGI, Head of Institution, EC Chairperson.

EventCoded termOnsetInitial report — 24 hDetailed analysed report — 14 dCriteria met
SAE-001AIIA-SAN-DEL-007 · SANHepatic enzyme increasedHepatobiliary06 Sept 2026 11:00Hospitalisation
SAE-002AIIA-MAD-DEL-004 · MADAngioedemaSkin and subcutaneous06 Sept 2026 23:00Hospitalisation
SAE-003AIIA-AMV-JAM-003 · AMVFemur fractureInjury and procedural29 Aug 2026 08:00Submitted in windowHospitalisationDisability
SAE-004AIIA-YAK-DEL-002 · YAKSudden cardiac deathCardiovascular29 Jul 2026 06:00Submitted in windowSubmitted in windowDeath
SAE-005AIIA-TAM-DEL-005 · TAMAnaphylactoid reactionRespiratory16 Aug 2026 11:00Submitted in windowSubmitted in windowLife-threateningHospitalisation
SAE-006AIIA-GRH-DEL-006 · GRHDehydrationMetabolism and nutrition11 Jul 2026 14:00Submitted in windowSubmitted in windowHospitalisation
SAE-007AIIA-KIT-DEL-004 · KITVertigoEar and labyrinth23 Aug 2026 09:00Submitted in windowSubmitted in windowDisability

Timelines are as recorded in the project research brief and are corroborated across academic teaching sources; verify against the Gazette notification G.S.R. 227(E) dated 19 March 2019 or CDSCO's published text before operational use.

Compensation decision chain

NDCT Rules 2019 — a four-stage, deadline-driven workflow with named actors: 30 → 60 → 90 → 30 days

2 active cases

COMP-004 · linked to SAE-004

Participant AIIA-YAK-DEL-002

Stage 2 of 4 in progress
30 days

EC Chairperson

→ DCGI

Completed 18 Aug 2026
260 days

Expert Committee Chairperson

→ DCGI

390 days

DCGI (compensation order)

→ Sponsor

Not yet started
430 days

Sponsor

→ Participant / nominee

Not yet started

COMP-006 · linked to SAE-006

Participant AIIA-GRH-DEL-006

Stage 3 of 4 in progress
30 days

EC Chairperson

→ DCGI

Completed 31 Jul 2026
60 days

Expert Committee Chairperson

→ DCGI

Completed 02 Sept 2026
390 days

DCGI (compensation order)

→ Sponsor

430 days

Sponsor

→ Participant / nominee

Not yet started

Adverse events — SDTM AE domain

AETERM is the verbatim investigator record. AEDECOD is the coded term. They are separate columns because coding never overwrites the source.

Terminology demo — illustrative subset only. Illustrative term subset. Production deployment requires licensed MedDRA and WHODrug. MedDRA is available at no charge to non-profit and educational institutions; WHODrug Global is available at no charge to national pharmacovigilance centres in the WHO Programme for International Drug Monitoring.

Subject IDUSUBJIDAETERMverbatim, as reportedAEDECODcoded termAEBODSYSsystem organ classAESEVAESERCausalityAERELOnsetAESTDTCOutcomeAEOUTReporting status
AIIA-MAD-DEL-004MAD · DEL“swelling of lips and face within 2 hours of dose, admitted to emergency”AngioedemaSkin and subcutaneousSEVERE
YAESHOSP
ProbableNaranjo06 Sept 2026RECOVERING/RESOLVING
AIIA-SAN-DEL-007SAN · DEL“SGPT and SGOT raised on routine week-8 bloods, patient admitted for observation”Hepatic enzyme increasedHepatobiliarySEVERE
YAESHOSP
PossibleWHO-UMC06 Sept 2026NOT RECOVERED/NOT RESOLVED
AIIA-AMV-JAM-003AMV · JAM“fall in bathroom at home, fracture neck of femur, operated”Femur fractureInjury and proceduralSEVERE
YAESHOSPAESDISAB
Not relatedWHO-UMC29 Aug 2026RECOVERING/RESOLVING
AIIA-KIT-DEL-004KIT · DEL“severe vertigo, recurrent falls, now unable to walk without support”VertigoEar and labyrinthSEVERE
YAESDISAB
PossibleWHO-UMC23 Aug 2026NOT RECOVERED/NOT RESOLVEDSubmitted in window
AIIA-TAM-DEL-005TAM · DEL“sudden breathlessness and wheeze after first dose, required nebulisation and admission”Anaphylactoid reactionRespiratorySEVERE
YAESLIFEAESHOSP
ProbableWHO-UMC16 Aug 2026RECOVERED/RESOLVEDSubmitted in window
AIIA-YAK-DEL-002YAK · DEL“found unresponsive at home, declared dead on arrival, cardiac cause suspected”Sudden cardiac deathCardiovascularSEVERE
YAESDTH
UnlikelyNaranjo29 Jul 2026FATALSubmitted in window
AIIA-GRH-DEL-006GRH · DEL“persistent loose stools with dehydration, hospital stay extended by 4 days”DehydrationMetabolism and nutritionMODERATE
YAESHOSP
PossibleNaranjo11 Jul 2026RECOVERED/RESOLVEDSubmitted in window
AIIA-GRH-DEL-014GRH · DEL“low grade fever 99.4 F for one day”PyrexiaGeneralMODERATENNot relatedWHO-UMC05 Sept 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-JAI-038SAN · JAI“discomfort in upper abdomen after food”Abdominal discomfortGastrointestinalMILDNUnlikelyNaranjo05 Sept 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-ONC-DEL-002ONC · DEL“mouth feels dry, needs frequent water”Dry mouthGastrointestinalMILDNPossibleWHO-UMC28 Aug 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-CHT-DEL-003CHT · DEL“difficulty falling asleep since starting medicine”InsomniaNervous systemMODERATENPossibleNaranjo21 Aug 2026NOT RECOVERED/NOT RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-016GRH · DEL“burning sensation in chest at night”DyspepsiaGastrointestinalMILDNProbableWHO-UMC18 Aug 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-SAN-JAI-009SAN · JAI“burning sensation in chest at night”DyspepsiaGastrointestinalMODERATENPossibleWHO-UMC16 Aug 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-DEL-015SAN · DEL“knee pain increased for 2 days”ArthralgiaMusculoskeletalMILDNUnlikelyWHO-UMC12 Aug 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-DEL-032SAN · DEL“mouth feels dry, needs frequent water”Dry mouthGastrointestinalMODERATENProbableNaranjo01 Aug 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-MAD-DEL-006MAD · DEL“difficulty falling asleep since starting medicine”InsomniaNervous systemMILDNProbableNaranjo30 Jul 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-JAI-030SAN · JAI“no bowel movement for 3 days”ConstipationGastrointestinalSEVERENNot relatedWHO-UMC30 Jul 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-JAI-033SAN · JAI“no bowel movement for 3 days”ConstipationGastrointestinalMILDNUnlikelyNaranjo30 Jul 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-005GRH · DEL“giddiness on standing up quickly”DizzinessNervous systemMILDNCertainNaranjo26 Jul 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-YAK-DEL-004YAK · DEL“knee pain increased for 2 days”ArthralgiaMusculoskeletalMILDNPossibleWHO-UMC22 Jul 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-TAM-DEL-004TAM · DEL“vomited once, watery”VomitingGastrointestinalSEVERENPossibleWHO-UMC17 Jul 2026NOT RECOVERED/NOT RESOLVEDNot reportable as an SAE
AIIA-CHT-DEL-004CHT · DEL“itching all over body, worse at night”PruritusSkin and subcutaneousMILDNPossibleNaranjo16 Jul 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-MED-DEL-001MED · DEL“itching all over body, worse at night”PruritusSkin and subcutaneousMILDNNot relatedWHO-UMC12 Jul 2026NOT RECOVERED/NOT RESOLVEDNot reportable as an SAE
AIIA-CHT-DEL-004CHT · DEL“knee pain increased for 2 days”ArthralgiaMusculoskeletalMILDNUnlikelyWHO-UMC11 Jul 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-016GRH · DEL“vomited once, watery”VomitingGastrointestinalMILDNNot relatedWHO-UMC10 Jul 2026NOT RECOVERED/NOT RESOLVEDNot reportable as an SAE
AIIA-KIT-KOL-002KIT · KOL“loose motions 3-4 times since morning”DiarrhoeaGastrointestinalMILDNUnlikelyWHO-UMC08 Jul 2026UNKNOWNNot reportable as an SAE
AIIA-AMV-DEL-002AMV · DEL“headache, frontal, dull, 2 days”HeadacheNervous systemMILDNPossibleWHO-UMC29 Jun 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-TAM-DEL-003TAM · DEL“burning sensation in chest at night”DyspepsiaGastrointestinalMILDNNot relatedNaranjo21 Jun 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-009GRH · DEL“vomited once, watery”VomitingGastrointestinalMODERATENNot relatedWHO-UMC20 Jun 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-DEL-017SAN · DEL“itchy red patches over both forearms”RashSkin and subcutaneousMILDNPossibleNaranjo16 Jun 2026NOT RECOVERED/NOT RESOLVEDNot reportable as an SAE
AIIA-AMV-DEL-002AMV · DEL“knee pain increased for 2 days”ArthralgiaMusculoskeletalMODERATENUnlikelyWHO-UMC14 Jun 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-MAD-JAI-010MAD · JAI“itching all over body, worse at night”PruritusSkin and subcutaneousSEVERENNot relatedWHO-UMC09 Jun 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-JAI-029SAN · JAI“burning sensation in chest at night”DyspepsiaGastrointestinalMILDNProbableWHO-UMC05 Jun 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-007GRH · DEL“blurring of vision for a few minutes”Vision blurredEyeMODERATENProbableWHO-UMC02 Jun 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-ARD-BLR-003ARD · BLR“vomited once, watery”VomitingGastrointestinalMODERATENUnlikelyWHO-UMC27 May 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-GRH-DEL-016GRH · DEL“discomfort in upper abdomen after food”Abdominal discomfortGastrointestinalMILDNNot relatedNaranjo24 May 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-ONC-DEL-002ONC · DEL“nausea after morning dose, no vomiting”NauseaGastrointestinalMILDNPossibleWHO-UMC21 May 2026RECOVERING/RESOLVINGNot reportable as an SAE
AIIA-GRH-DEL-004GRH · DEL“knee pain increased for 2 days”ArthralgiaMusculoskeletalMODERATENPossibleNaranjo20 May 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-MAD-DEL-007MAD · DEL“mild body ache after Shodhana procedure”MyalgiaMusculoskeletalMILDNProbableWHO-UMC11 May 2026RECOVERED/RESOLVEDNot reportable as an SAE
AIIA-SAN-DEL-001SAN · DEL“sneezing and running nose for 3 days”RhinitisRespiratoryMILDNPossibleWHO-UMC10 May 2026RECOVERING/RESOLVINGNot reportable as an SAE

Showing 40 of 40 events. AESEV (severity — how bad it felt) and AESER (seriousness — a regulatory classification that triggers reporting duties) are different fields: a severe headache may be non-serious, and a brief hospitalisation is serious even when mild.

AE frequency by system organ class

Illustrative groupings — no MedDRA SOC codes are attached

Adverse event trend

Onsets by month, with the serious subset overlaid

DSMB summary

Aggregate safety metrics prepared for the Data Safety Monitoring Board

Next review in 21 days

Total events

40

Serious events

7

SAE rate per 100 enrolled

5.8

Events assessed related

23

Withdrawals due to an AE

11

Deaths

1

Causality is assessed on the WHO-UMC scale and the Naranjo algorithm. No stopping rule has been triggered on any study in this portfolio.

Advertisement surveillance

Surveillance of misleading advertisements in print and electronic media is one of the five stated objectives of the Central Sector Scheme for Pharmacovigilance of ASU&H Drugs, which AIIA coordinates as NPvCC.

ADV-2026-041DigitalAyurveda

Claims a proprietary churna 'completely cures diabetes in 30 days, stop your other medicines'

Social media video advertisement · flagged 04 Sept 2026

Under reviewHigh
ADV-2026-039TelevisionAyurveda

Herbal oil advertised as a guaranteed remedy for arthritis with 'no side effects whatsoever'

Regional satellite channel, evening slot · flagged 29 Aug 2026

Referred to MinistryHigh
ADV-2026-036PrintUnani

Unani formulation advertised for a condition listed under the Drugs and Magic Remedies Act schedule

Vernacular daily, classified section · flagged 21 Aug 2026

Notice issuedHigh
ADV-2026-030DigitalSiddha

Siddha preparation listed with an unsubstantiated 'clinically proven' badge and no trial reference

E-commerce product listing · flagged 10 Aug 2026

Notice issuedMedium
ADV-2026-022RadioHomoeopathy

Homoeopathic remedy promoted for immunity with an implied disease-prevention claim

FM sponsored segment · flagged 25 Jul 2026

ClosedLow