Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients (FANG30-RA)
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ClinicalTrials.gov Identifier: NCT00749645 |
Recruitment Status :
Completed
First Posted : September 9, 2008
Last Update Posted : June 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Arthritis, Rheumatoid | Drug: FANG(30) Drug: Placebo | Phase 2 |

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 |

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)
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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)
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Drug: Placebo
Placebo 30mg tabs, 3/day, 105 days continuously.
Other Name: FARMINDUSTRIA Specific Placebo tabs/Lot FANG06 & 01-ANDRO-07 |
- 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:Day1, end of week2, then every 4 weeks for 3 mo, it will be measured: Morning stiffness duration. [ Time Frame: Monthly ]
- Symptoms relief by patient and researcher. [ Time Frame: Monthly ]
- Paracetamol used as rescue medicine for pain. [ Time Frame: Monthly ]
- Tolerability by patient and researcher. [ Time Frame: Monthly ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00749645
Chile | |
HOSPITAL REGIONAL de OSORNO | |
Osorno, Los Lagos, Chile, 5290000 | |
Hospital Clínico Regional | |
Valdivia, Los Ríos, Chile, 5090000 |
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 |
Publications of Results:
Other Publications:
Responsible Party: | Juan C. Bertoglio, MD, Principal Investigator, Universidad Austral de Chile |
ClinicalTrials.gov 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 |
Arthritis, Rheumatoid, Andrographolides treatment, Efficacy. |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |