NCT00528151

CompletedPhase 3

A Randomized, Double-blind, Placebo-controlled Trial of Curc...

Mahidol University Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

123/2547

Study Type

interventional

Estimated enrollment

70

Locations

1 country

Sites

1

Timeline

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2007

Actual (reported)

Brief Summary

Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production. Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation. Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 70 participants
Study completion date: December 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 11, 2007
Actual (reported)
First Posted
September 12, 2007
Actual (reported)
Study Completion
December 2007
Actual (reported)

Last Updated: December 24, 2012
Status Verified: August 2004
Last Update Submitted: December 20, 2012

Conditions

Optic Atrophy, Hereditary, Leber

Keywords

Curcumin, LHON, antioxidant, visual outcome

Outcome Measures

Primary Outcomes (1)

visual outcome
1 year

Study Arms (1)

2

PLACEBO COMPARATOR

1. curcumin 2. placebo

Drug: curcumin

Interventions

curcuminDrug

curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age8 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

LHON patient with 11778 point mutation

You may not qualify if:

Sponsors & Collaborators

Mahidol University
Otherlead

Study Sites (1)

Professor Wanicha Chuenkongkaew

Bangkok, Bangkok, 10700, Thailand

MeSH Terms

Conditions

Optic Atrophy, Hereditary, Leber

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Optic Atrophies, HereditaryOptic AtrophyOptic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesEye Diseases, HereditaryEye DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Professor Wanicha L Chuenkongkaew, MD
Mahidol University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2007

Actual (reported)

Phase 3

Completed

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Phase 3Completed

NCT03406104

RESCUE and REVERSE Long-term Follow-up

Phase 3Completed

NCT02255370

Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease

Phase 3Completed

NCT02064673

Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy

Phase 3Recruiting

NCT03769766

Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance

Phase 3Recruiting

NCT01831193

Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease

Phase 3Completed

LHON patient with other point mutation

Contact the study team to confirm eligibility.

Mitochondrial Diseases

Metabolic Diseases

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Last Updated

December 24, 2012

Record last verified: 2004-08

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00528151
Data provider: ClinicalTrials.gov
Source updated: 2012-12-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:18 UTC

Locations

TH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations