Safety and Efficacy of a Traditional Herbal Medicine (Throat Coat®) in Symptomatic Temporary Relief of Pain in Patients with Acute Pharyngitis: A Multicenter, Prospective, Randomized, Double-Blinded,           Placebo-Controlled Study

ObjectiveTo evaluate the safety and efficacy of removing blood stasis (RBS) herbal medicine for the treatment of acute intracerebral haemorrhage (AICH) within a 6-hour time window.Study designA randomised, multicentre, double-blind, placebo-controlled study performed in 14 hospitals in China.Participants and interventionsPatients with AICH were randomly assigned to receive a placebo, the ICH-1 (Intracerebral Haemorrhage) formula (eight herbs, including the RBS herbs hirudo and tabanus) or the ICH-2 formula (six herbs without the RBS herbs hirudo and tabanus) within 6 hours of ICH onset.OutcomesThe primary safety outcome was the incidence of haematoma enlargement at 24 hours and at 10 days after treatment. The secondary outcome was the incidence of poor prognosis (mortality or modified Rankin Scale score ≥5) assessed at 90 days after symptom onset.ResultsA total of 324 subjects were randomised between October 2013 and May 2016: 105 patients received placebo; 108 patients received the ICH-1 formula; and 111 patients received the ICH-2 formula. The incidence of haematoma enlargement at 24 hours was 7.8% in the placebo group, 12.3% in the ICH-1 group and 7.5% in the ICH-2 group; the incidence of haematoma enlargement on day 10 was 1.1% in the placebo group, 1.1% in the ICH-1 group, and 3.1% in the ICH-2 group, with no significant differences among the groups (P>0.05). The mortality rates were 3.8% in the placebo group, 2.8% in the ICH-1 group, and 0.9% in the ICH-2 group; the incidences of poor prognosis were 7.1% in the placebo group, 6.0% in the ICH-1 group and 4.8% in the ICH-2 group at 3 months, with no significant differences among the groups (p>0.05). However, the overall frequency of treatment-emergent adverse events in the ICH-1 group (12.1%) was higher among the three groups (5.8% and 2.8%, respectively, p<0.05). All three cases of serious adverse events were in the ICH-1 group.ConclusionsUltra-early administration of ICH-1 formula for AICH patients did not exert significant beneficial effects on clinical outcomes but increased the risk of bleeding, which probably resulted from the inclusion of RBS herbal medicines in ICH-1.Trialregistration numberNCT01918722.

Download Full-text

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/4813601 ◽

2018 ◽

Vol 2018 ◽

pp. 1-11 ◽

Cited By ~ 4

Author(s):

K. N. Mala ◽

Jestin Thomas ◽

Das S. Syam ◽

Balu Maliakel ◽

I. M. Krishnakumar

Keyword(s):

Functional Dyspepsia ◽

Group Versus ◽

Controlled Study ◽

Present Contribution ◽

Safety And Efficacy ◽

Postprandial Fullness ◽

Synthetic Drugs ◽

Hard Shell ◽

Double Blinded ◽

Ferula Asafoetida

Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida (Ferula asafoetida) in FD for the first time. In the double-blinded, placebo-controlled study, 43 subjects diagnosed to have moderate to severe discomforts of nonulcer FD were randomized to receive hard-shell capsules (250 mg × 2/day) of either placebo (n=22) or a food-grade formulation of asafoetida (Asafin) (n=21) for 30 days. When evaluated by a set of validated indexing tools (GSRS, GDSS, and NDI), almost 81% in the Asafin group showed significant (p < 0.01) improvement in the overall score and quality of life as compared to the placebo. At the end of the study, 66% of subjects in the Asafin group remained symptoms-free. Although the symptoms score improved significantly in both the groups (from -5.67 to -25.29 in Asafin group versus -1.55 to -6.0 in the placebo; p ≤ 0.001), the relative percentage of subjects in the Asafin group with more than 80% reduction in various symptoms were: bloating (58%), appetite (69%), postprandial fullness (74%) motion sickness (75%), and digestion (77%) as compared to less than 10% nonspecific improvement in the placebo group. All the subjects remained safe with no adverse events or variations in haematological and biochemical parameters. The study was registered at http://ctri.nic.in/ (CTRI/2018/ 01/011149).

Download Full-text

Phytochemistry, Traditional Use and Pharmacological Activity of Picrasma quassioides: A Critical Reviews

Nutrients ◽

10.3390/nu12092584 ◽

2020 ◽

Vol 12 (9) ◽

pp. 2584

Author(s):

Muhammad Daniel Hakim Mohd Jamil ◽

Muhammad Taher ◽

Deny Susanti ◽

Md Atiar Rahman ◽

Zainul Amiruddin Zakaria

Keyword(s):

Herbal Medicine ◽

Traditional Herbal Medicine ◽

Pharmacological Activities ◽

Traditional Use ◽

Safety And Efficacy ◽

Picrasma Quassioides ◽

Anti Cancer ◽

Real Value ◽

High Doses ◽

Toxicity Effects

Picrasma quassioides is a member of the Simaroubaceae family commonly grown in the regions of Asia, the Himalayas, and India and has been used as a traditional herbal medicine to treat various illnesses such as fever, gastric discomfort, and pediculosis. This study aims to critically review the presence of phytochemicals in P. quassioides and correlate their pharmacological activities with the significance of its use as traditional medicine. Data were collected by reviewing numerous scientific articles from several journal databases on the pharmacological activities of P. quassioides using certain keywords. As a result, approximately 94 phytochemicals extracted from P. quassioides were found to be associated with quassinoids, β-carbolines and canthinones. These molecules exhibited various pharmacological benefits such as anti-inflammatory, antioxidant, anti-cancer, anti-microbial, and anti-parasitic activities which help to treat different diseases. However, P. quassioides were also found to have several toxicity effects in high doses, although the evidence regarding these effects is limited in proving its safe use and efficacy as herbal medicine. Accordingly, while it can be concluded that P. quassioides may have many potential pharmacological benefits with more phytochemistry discoveries, further research is required to determine its real value in terms of quality, safety, and efficacy of use.

Download Full-text

Safety and Efficacy of Intravenous Zanamivir in Preventing Experimental Human Influenza A Virus Infection

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.43.7.1616 ◽

1999 ◽

Vol 43 (7) ◽

pp. 1616-1620 ◽

Cited By ~ 90

Author(s):

David P. Calfee ◽

Amy W. Peng ◽

Lindsey M. Cass ◽

Monica Lobo ◽

Frederick G. Hayden

Keyword(s):

Influenza A Virus ◽

Influenza A ◽

Controlled Study ◽

Nasal Discharge ◽

Upper Respiratory Tract ◽

Human Influenza ◽

Safety And Efficacy ◽

Viral Shedding ◽

Respiratory Tract Illness ◽

Double Blinded

ABSTRACT Zanamivir is a potent inhibitor of influenza A and B virus neuraminidases and is active topically in experimental and natural human influenza. We conducted this double-blinded, placebo-controlled study to evaluate the safety and efficacy of intravenously administered zanamivir. Susceptible volunteers were randomized to receive either saline or zanamivir (600 mg) intravenously twice daily for 5 days beginning 4 h prior to intranasal inoculation with ∼105 50% tissue culture infectious doses (TCID50) of influenza A/Texas/36/91 (H1N1) virus. Reductions in the frequency of viral shedding (0% versus 100% in placebo, P < 0.005) and seroconversion (14% versus 100% in placebo, P < 0.005) and decreases in viral titer areas under the curve (0 versus 11.6 [median] log10 TCID50 · day/ml in placebo,P < 0.005) were observed in the zanamivir group, as were reductions in fever (14% versus 88% in placebo,P < 0.05), upper respiratory tract illness (0% versus 100% in placebo, P < 0.005), total symptom scores (1 versus 44 [median] in placebo, P < 0.005), and nasal-discharge weight (3.9 g versus 17.5 g [median] in placebo, P < 0.005). Zanamivir was detectable in nasal lavage samples collected on days 2 and 4 (unadjusted median concentrations, 10.5 and 12.0 ng/ml of nasal wash, respectively). This study demonstrates that intravenously administered zanamivir is distributed to the respiratory mucosa and is protective against infection and illness following experimental human influenza A virus inoculation.

Download Full-text