Tang T. et al. Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine. Aliment Pharmacol Ther. 2011 Jan;33(2):194-202.
This was an 8-week randomized, double-blind, parallel group study that compared the efficacy of an Andrographis extract (HMPL-04) to slow-release mesalamine granules in 120 patients with mild-to-moderate active ulcerative colitis. Assessments of clinical response were made at baseline and every 2 weeks, and colonoscopy was performed at baseline and at 8 weeks. Clinical response was defined as remission (no symptoms), partial remission (50% reduction in symptoms), or improvement (25% reduction in symptoms). Secondary endpoints were based on colonoscopy findings of inflammation and mucosal appearance, and histological improvement at biopsy. At week 8, remission was observed in 74% (p<0.001) and 28% of the HMPL-04 treated patients (n=60), and 71% (p<0.001) and 24% of the mesalamine-treated patients (n=60), respectively. But the differences were not statistically significant.
The authors concluded that HMPL-04 may be an effective alternative to mesalamine treatment for ulcerative colitis.
Saxena RC, et al. A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection. Phytomedicine. 2010 Mar;17(3-4):178-85.
This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy of an Andrographis extract in patients with uncomplicated upper respiratory tract infection (URTI). Patients (n=223) were randomized into groups to receive either Andrographis extract (n=112) or placebo (n=111). Patients self-evaluated and scored symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue, and sleep disturbances using a Visual Analogue Scale. For both groups, mean symptom scores showed a significantly decreasing trend (p<0.05) from day 1 to 3, but from day 3 to 5, most of the symptoms in the placebo group either remained unchanged or worsened. However, in the Andrographis extract group, all symptoms (except earache) continued to show a significantly decreasing trend (p<0.05) from days 3 to 5. By day 5, improvement in overall symptom scores in the Andrographis extract group was significantly better than placebo (p<0.05), a decrease of 155.49+7.26 points vs 73.52+6.98 points, respectively. A few minor adverse effects were observed, with no significant difference between groups. The investigators concluded that Andrographis extract was effective in reducing the symptoms of URTI.
Burgos RA, et al. Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Clin Rheumatol. 2009 Aug;28(8):931-46.
This randomized, double-blind, placebo-controlled trial investigated the efficacy of Andrographis extract tablets (ParactinÒ) in patients (n=60) with active rheumatoid arthritis (RA). After a 2 week washout period, patients received either Andrographis extract (n=30) or placebo (n=30) for 14 weeks. The primary outcome measure was pain intensity, evaluated by a horizontal visual analog pain scale (VAPS). By week 14, joint pain intensity decreased in the treatment group, however this difference was not statistically significant compared to placebo. However, by week 1, the treatment group experienced a statistically significant decrease in other RA symptoms (tender joints [p=0.001], number of swollen joints [p=0.02], total grade of swollen joints [p=0.010], number of tender joints [p=0.033], total grade of swollen joints [p=0.01], total grade of tender joints [p=0.002], and health assessment quality survey [p<0.001]) compared to placebo. A significant reduction in rheumatoid factors IgA (p=0.101) and C4, (p=0.031) was also observed in the treatment group compared to placebo. The authors concluded that Andrographis may be a useful complementary treatment for RA, however a longer and larger trial is needed to confirm these results.
Spasov AA, Ostrovskij OV, Chernikov MV, Wikman G. Comparative controlled study of Andrographis paniculata fixed combination, Kan Jang and an Echinacea preparation as adjuvant, in the treatment of uncomplicated respiratory disease in children. Phytother Res 2004;18(1):47-53.
A three arm study was conducted comparing Kan Jang preparation with Immunal, an Echinacea-based preparation, as adjuvants to a standard regimen of warm drinks, mouth gargles and paracetamol prn in children aged 4 to 11 suffering from the common cold over 10 days. 130 children were randomized to receive either standard treatment, or standard treatment with either Kan Jang or Immunal. Adjuvant treatment with Kan Jang was more effective than Immunal. Cold symptoms were less severe in the Kan Jang group, particularly in the amount of nasal secretion and congestion reported. Kan Jang accelerated recovery time compared to Immunal which did not demonstrate the same efficacy. There was less use of standard medication in the Kan Jang group, and treatment was well tolerated.