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Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients (FANG30-RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749645
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : June 23, 2016
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by (Responsible Party):
Juan C. Bertoglio, MD, Universidad Austral de Chile

Brief Summary:
This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult patients affected with active Rheumatoid Arthritis. Also, to evaluate the effect of an andrographolide natural formula, identified as FANG(30) or "the study product", on the immunological functions that influence chronic inflammatory process in these patients, who could benefit with this treatment.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: FANG(30) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients
Study Start Date : October 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 - FANG(30)
1 - Active comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the active product, in addition to base medication (Mtx + Pdn)
Drug: FANG(30)
Andrographolide formula Oral tablets, 30mg, three times per day, during a total of 105 continuous days.
Other Name: FANG 30mg tablets, FARMINDUSTRIA, Lots FANG06 & 01-ANDRO-07

Placebo Comparator: 2 - Placebo
2 - Placebo comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the placebo formulation, in addition to base medication (Mtx + Pdn)
Drug: Placebo
Placebo 30mg tabs, 3/day, 105 days continuously.
Other Name: FARMINDUSTRIA Specific Placebo tabs/Lot FANG06 & 01-ANDRO-07

Primary Outcome Measures :
  1. Primary: Day1, end of week2, then every 4 weeks for 105 days, the following will be measured: 1.Inflamed and painful joints count. 2. Intensity of pain by patient on Visual Analogue Scale(VAS). 3. Overall improvement by HAQ and SF 36 (enclosed). [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Secondary:Day1, end of week2, then every 4 weeks for 3 mo, it will be measured: Morning stiffness duration. [ Time Frame: Monthly ]
  2. Symptoms relief by patient and researcher. [ Time Frame: Monthly ]
  3. Paracetamol used as rescue medicine for pain. [ Time Frame: Monthly ]
  4. Tolerability by patient and researcher. [ Time Frame: Monthly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients, between 18 and 70 years of age.
  • Clinical diagnosis of RA, based on typical history and clinical presentation of the patient according to the diagnostic criteria of the American College of Rheumatology (ACR), 1987.
  • Active AR characterized by pain and increase in joint volume, in at least 1 joint, associated to VHS > 20 mm/h and/or PCR > 0,6 ng/ml.
  • Ambulatory patient requiring treatment with anti-inflammatory drugs, whom is neither receiving non-steroidal anti-inflammatory drugs (NSAIDs) nor any other drugs, except Paracetamol, for at least 4 weeks previous to the beginning of the study.
  • Also, patients with RA treated with Prednisone and/or Chloroquine and Methotrexate in stable doses for at least 6 weeks, with active arthritis, and willing to participate in the study.
  • Willing to come to regular controls.
  • Written consent signed by the patient, according to the criteria and text approved by the local Scientific Ethical Committee.

Exclusion Criteria:

  • Pregnant women, breast feeding, childbirth, potentially fertile and / or not following adequate contraceptive methods.
  • Non degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA (i.e. Gout, Pseudogout, Chondrocalcinosis, Psoriatic Arthritis, Infectious Arthritis, Reactive Arthritis or Spondylitic Arthritis).
  • Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients.
  • Treatment with intra-joint injection with corticosteroids one month before treatment.
  • Ongoing treatment with anticoagulants, hydantoins or lithium.
  • Presence or history of digestive hemorrhage, peptic ulcer in the 6 previous months or hemorrhagic ulcer any time during the past, gall bladder stones or dysfunction.
  • Hypersensitivity and / or intolerant to NSAIDs, including patients with bronchospam history induced by Aspirin.
  • Evidence of renal, hepatic and severe hematopoietic diseases, and heart failure revealed by laboratory tests or other tests.
  • History of using any other test drug, one month before to the beginning of this trial.
  • Patients with tranquilizers, hypnotic or excess of alcohol, which can interfere with the perception of pain.
  • Necessity of any other therapy for arthrosis, except Paracetamol used as a rescue drug during the period of study. Also exercise and/or physiotherapy, if ongoing, can continue without modification.
  • Not willing to come for regular follow ups during the period of duration of the study.
  • Non cooperative attitude.
  • Any condition that in the opinion of the physician, does not justify the inclusion of the patient in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749645

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Osorno, Los Lagos, Chile, 5290000
Hospital Clínico Regional
Valdivia, Los Ríos, Chile, 5090000
Sponsors and Collaborators
Juan C. Bertoglio, MD
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
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Study Chair: Juan L. Hancke, DVM, PhD Universidad Austral de Chile
Study Director: Rafael A. Burgos, DVM, MSc Universidad Austral de Chile
Principal Investigator: Juan C. Bertoglio, MD Universidad Austral de Chile
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Juan C. Bertoglio, MD, Principal Investigator, Universidad Austral de Chile Identifier: NCT00749645    
Other Study ID Numbers: PCT06-AG-02
DO4I1240FONDEF ( Other Identifier: CHILE Scientific Technological Development Fund )
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: October 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All these data has been accepted for publication in Clinical Rheumatology
Keywords provided by Juan C. Bertoglio, MD, Universidad Austral de Chile:
Arthritis, Rheumatoid, Andrographolides treatment, Efficacy.
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases