Shahid Akbar. 2011. Andrographis paniculata: a review of pharmacological activities and clinical effects.Altern Med Rev. 16, 1: 66-77.

......................................................................

Tang, T., S. R. Targan, Z.-S. Li, C. Xu, V. S. Byers and W. J. Sandborn. 2011. Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine. Aliment Pharmacol Ther. 33, 2: 194-202.

Abstract:

BACKGROUND: Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, and prevents colitis in animal models.

AIM: To determine the efficacy and safety of HMPL-004 in patients with mild-to-moderate ulcerative colitis.

METHODS: A randomised, double-blind, multicentre, 8-week parallel group study was conducted using HMPL-004 1200 mg/day compared with 4500 mg/day of slow release mesalazine (mesalamine) granules in patients with mild-to-moderately active ulcerative colitis. Disease activity was assessed at baseline and every 2 weeks for clinical response, and at baseline and 8 weeks by colonoscopy.

RESULTS: One hundred and twenty patients at five centres in China were randomised and dosed. Clinical remission and response were seen in 21% and 76% of HMPL-004-treated patients, and 16% and 82% of mesalazine-treated patients. By colonoscopy, remission and response were seen in 28% and 74% of HMPL-004-treated patients and 24% and 71% of mesalazine-treated patients, respectively. There was no significant difference between the two treatment groups.

CONCLUSION: HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.

.....................................................................

Coon, J. T. and E. Ernst. 2004. Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy. Planta Med. 70, 4: 293-298.

Abstract: Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.

..........................................................................................

Naik, S. R. and A. Hule. 2009. Evaluation of immunomodulatory activity of an extract of andrographolides from Andographis paniculata. Planta Med. 75, 8: 785-791.

Abstract: The immunomodulatory activity of HN-02, an extract containing a mixture of andrographolides (i.e., andrographolide [88 +/- 5 %] plus 14-deoxyandrographolide and 14-deoxy-11,12-didehydroandrographolide together [12 +/- 3 %]) in a pure powder form was evaluated at 1.0, 1.5, and 2.5 mg/kg on different in vivo and in vitro experimental models. In a delayed-type hypersensitivity (DTH) mouse model, potentiation of the DTH reaction was observed after treatment with cyclophosphamide (CYP) and HN-02 individually. However, CYP potentiation of the DTH reaction was reversed by HN-02 pretreatment. Furthermore, HN-02 treatment elevated the depressed hemagglutination antibody (HA) titer and increased the number of plaque-forming cells (PFCs) in the spleen cells of mice that had been treated with CYP and challenged with sheep red blood cells (SRBC). Further, it was also found that HN-02 treatment stimulated phagocytosis in mice. A significant increase in total WBC count and relative weight of spleen and thymus was observed in mice during 30 days of treatment with HN-02. The present experimental findings demonstrate that HN-02 has the ability to enhance immune function, possibly through modulation of immune responses altered during antigen interaction, and to reverse the immunosuppression induced by CYP.

..............................................................................

Saxena, R. C., R. Singh, P. Kumar, S. C. Yadav, M. P. S. Negi, V. S. Saxena, A. J. Joshua, V. Vijayabalaji, K. S. Goudar, K. Venkateshwarlu and A.  Amit. 2010. A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata(KalmCold^TM) inpatients with uncomplicated upper respiratory tract infection. Phytomedicine. 17, 3-4: 178-185.

Abstract;  A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of  KalmCold^TM, an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection(URTI).The assessment involved quantification of symptom scores by Visual Analogue Scale.Nine self evaluated symptoms of cough,expectoration,nasal discharge,headache,fever,sore throat,earache,malaise/fatigue and sleep disturbance were scored.A total of 223 patients of both sexes were randomized in two groups which received either KalmCold^TM(200 mg/day) or placebo in a double blind manner.In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough,headache and earache) or got aggravated (sorethroat and sleep disturbance) whereas in KalmCold^TM treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p ≤ 0.05 from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold^TMtreated group all symptoms improved significantly (p ≤  0.05) except earache.Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold^TM treated group improved significantly (p ≤  0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p ≤ 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold^TM treated group showed significant improvement (p ≤ 0.05). On between groups analysis, KalmCold^TM group showed significant reduction (p ≤  0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold^TM treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z=0.63; p > 0.05). The comparison of overall efficacy of KalmCold^TM over placebo was found to be significant (p ≤  0.05) and it was 2.1times (52.7%) higher than placebo.The findings of this studyr evealed that KalmCold^TM was effective in reducing symptoms of upper respiratory tract infection.

.....................................................................................................

Jarukamjorn, K. and N. Nemoto. 2008. Pharmacological Aspects of Andrographis paniculata on Health and Its Major Diterpenoid Constituent Andrographolide. Journal of Health Science 54, 4: 370-381

Abstract ; Nowadays, research on medical plants has attracted a lot of attention globally. A number of evidence has been accumulated to demonstrate promising potential of medical plants used in variuos traditional, complementary, and alternative systems. In recent years, a medical plant,Andrographis paniculata, and its major active phytochemicals have been extensively study for several pharmacological activies. To understand the mechanism of action,researches have to be carried out at molecular levels. The present review aims at compiling consequential compendium of   pharmacological benefits of health on this plant and its major diterpenoid constituent and andrographolide that have been tested in various experimental models using modern scientific methodologies.

..........................................................................................................................  

Amaryan, G., V. Astvatsatryan, E. Gabrielyan, A. Panossian, V. Panosyan and G. Wikman. 2003. Double blind, placebo-controlled, randomized, pilot clinical trial of ImmunoGuard^® – a standardized fixed combination of Andrographis paniculata Nees, with Eleutherococcus senticosus Maxim, Schizandra chinensis Bail. and Glycyrrhiza glabra L. extracts in patients with Familial Mediterranean Fever. Phytomedicine 10: 271–285

Abstract; Double blind, randomized, placebo controlled pilot study of ImmunoGuard^® – a standardized fixed combination of Andrographis paniculata Nees., Eleutherococcus senticosusMaxim., Schizandra chinensis Bail., and Glycyrrhiza glabra L. special extracts standardized for the content of Andrographolide (4 mg/tablet), Eleuteroside E, Schisandrins and Glycyrrhizin, was carried out in two parallel groups of patients. The study was conducted in 24 (3–15 years of both genders) patients with Familial Mediterranean Fever (FMF), 14 were treated with tablets of series A (verum)and 10 patients received series B product (placebo). The study medication was taken three times offour tablets daily for 1month. Daily dose of the andrographolide – 48 mg. The primary outcomemeasures in physician’s evaluation were related to duration, frequency and severity of attacks in FMF patients (attacks characteristics score). The patient’s self-evaluation was based mainly on symptoms – abdominal, chest pains, temperature, arthritis, myalgia, erysipelas-like erythema. All of 3 features (duration, frequency, severity of attacks) showed significant improvement in the verum group as compared with the placebo. In both clinical and self evaluation the severity of attacks was found to show the most significant improvement in the verum group. Both the clinical and laboratory results of the present phase II (pilot) clinical study suggest that ImmunoGuard^® is a safe and efficacious herbal drug for the management of patients with FMF.

..........................................................................................................................

Mkrtchyana, A., V. Panosyana, A. Panossianb, G. Wikmanb and H. Wagner. 2005. A phase I clinical study of Andrographis paniculata fixed combination Kan JangTM versus ginseng and valerian on the semen quality of healthy male subjects. Phytomedicine, 12: 403–409.

Abstract; The safety of different doses of Kan Jang^TM – a fixed combination of Andrographis paniculata special extract (SHA-10) and Acanthopanax senticosus – compared to two extensively used medicinal plants, Valeriana officinalis and Panax ginseng in the form of standardized extracts, has been examined. A phase I clinical study was designed to evaluate the effect on semen quality of healthy males in terms of spermatogenesis and quality of semen. The results of the study revealed no significant negative effect of Kan Jang on male semen quality and fertility, but rather a positive trend with respect to the number of spermatozoids in the whole ejaculate, the percentage of active (normokinetic) forms of spermatozoids, and fertility indexes, together with a decrease in the percentage of inactive (diskinetic) forms of spermatozoids. In the group receiving ginseng, no significant negative effects on the fertility parameters were revealed and there was a clear decrease in the percentage of diskinetic forms of spermatozoids. Subjects receiving valerian showed a temporary increase in the percentage of normokinetic spermatozoids and a decrease in diskinetic forms, but these changes had no effect on fertility indices. The results indicate that Kan Jang, ginseng and valerian are safe with respect to effects on human male sterility when administered at dose levels corresponding to approximately 3 times the human daily dose.

..........................................................................................................................

Chuthaputti, A., V. Pornpatkul and U. Suwankiri. 2005. The Efficacy of Andrographis paniculata (Burm. f.) Wall. ex Nees for the Relief of the Symptoms of Influenza. Journal of Thai Traditional & Alternative Medicine 5, 3: 257-266.

Abstract; Tablets or capsules of the dried aerial part of Andrographis paniculata (Burm.f.) Wall. ex Nees comprise a single herbal medicine selected for inclusion in the National List of Essential Drugs in Thailand for the relief of the symptoms of the common cold; however, there is no clinical evidence yet to support its similar use for influenza. Therefore, this study was conducted to determine if A. paniculata could also relieve the symptoms of influenza as it does in the common cold. A multi-center, randomized controlled open-label study was carried out in health-service centers and a hospital under the Nonthaburi Provincial Public Health Office in patients having a fever of 38°C or higher, respiratory and constitutional symptoms for no longer than 36 hours, and laboratory-confirmed as having influenza. Patients were randomly divided into two groups: Group I received paracetamol tablets at the dose of 1 gram every 6 hours for fever, headache and myalgia; and Group II received the same dose of paracetamol and A. paniculata capsules at the dose of 1.6 grams 4 times daily. Body temperatures were recorded and the severity of the symptoms of influenza, namely nasal congestion/ runny nose, sore throat, cough, headache, malaise, myalgia, fatigue, chill, and overall symptoms were determined by the Visual Analog Scale on the day of enrollment (Day 0) and on Days 2, 4 and 6 of the treatment. At the end of the study there were 10 patients in Group I and 15 patients in the Group II. It was found that in Group II, from Day 2 of the treatment, body temperature, the severity of overall symptoms and almost all the other symptoms of influenza, except for cough, were significantly improved compared with those of Day 0. Meanwhile, for Group I, on Day 2 only the body temperature, overall symptoms and malaise were significantly lower than the values on Day 0. When comparing the two groups, it was found that the severity of cough, fatigue, and overall symptoms of the group treated with paracetamol and A. paniculata was significantly lower than that of the group treated with paracetamol alone from Day 4 of the treatment. Eighty percent of the patients in Group II would choose the same medications again the next time they have influenza, while only 20 percent of the patients in Group I would do so. The numbers of patients who would choose the previously prescribed medications or new medication were statistically significantly different between the two groups. In conclusion, the present study showed that Andrographis paniculata, when given together with paracetamol, could significantly reduce the severity of the overall symptoms of influenza and induce a more rapid improvement of various symptoms of influenza better than paracetamol alone did. This finding warrants a recommendation for usingAndrographis paniculata for influenza in primary health care and inclusion on the National List of Essential Drugs as well as further study in a larger group of patients in the future.

..........................................................................................................................

Gabrielian, E. S., A. K. Shukarian, G. I. Goukasova, G. L. Chandanian, A. G. Panossian, G.  Wikman and H. Wagner. 2002. A double blind, placebo-controlled study of Andrographis paniculata fixed combination Kan Jang in the treatment of acute upper respiratory tract infections including sinusitis. Phytomedicine 9: 589–597.

Abstract; A double blind, placebo-controlled, parallel-group clinical study was carried out to evaluate the effect of an Andrographis paniculata (N.) extract SHA-10 fixed combination, Kan Jang, in the treatment of acute upper respiratory tract infections, including sinusitis. Ninety-five individuals in the treatment group and 90 individuals in the placebo group completed the study according to the protocol. The medication was taken for 5 days. Temperature, headache, muscle aches, throat symptoms, cough, nasal symptoms, general malaise and eye symptoms were taken as outcome measures with given scores. The total score analysis showed a highly significant improvement in the verum group versus the placebo. This result applied to the group as a whole and to the sinusitis subgroups. The individual symptoms of headache and nasal and throat symptoms together with general malaise showed the most significant improvement while cough and eye symptoms did not differ significantly between the groups. Temperature was moderately reduced in the verum group. It can be concluded that Kan Jang has a positive effect in the treatment of acute upper respiratory tract infections and also relieves the inflammatory symptoms of sinusitis. The study drug was well tolerated.

..........................................................................................................................

Kligler, B., C. lbricht, E. Basch, C. D. Kirkwood, T. R. Abrams, M. Miranda, K. P. S. Khalsa, M. Giles, H. Boon and J. Woods. 2006. ANDROGRAPHIS PANICULATA FOR THE TREATMENT OF UPPER RESPIRATORY INFECTION: A SYSTEMATIC REVIEW BY THE NATURAL STANDARD RESEARCH COLLABORATION. Explore 2, 1: 25-29.

Andrographis