Study design of herbal medicine clinical trials: a descriptive analysis of published studies investigating the effects of herbal medicinal products on human participants.

Background: Increasing global interest in natural therapies has led to a rise in the use of herbal medicines for managing various ailments. However, concerns about scientific evaluation have prompted a study aiming to assess the study design of herbal medicine clinical trials. This study aimed to provide a descriptive overview of the study design, characteristics, and methodologies of contemporary herbal medicine clinical trials.

Molecular mechanisms of antidiabetic effect of betulinic acid in lotus rhizome.

Objectives: To explain the bio-physiological mechanisms of the antidiabetic effect of betulinic acid in Lotus rhizome.

Background: Even though Sri Lankan native medicine uses Lotus rhizome as a medicinal food for diabetes mellitus, its antidiabetic property has not been scientifically explained yet. It is found to compose several medicinally active components with antidiabetic properties, including Betulinic acid.

Efficacy and safety of Sri Lankan traditional medicine regimen for knee osteoarthritis: study protocol for an open-label, active comparator, randomized controlled trial.

Background: Knee osteoarthritis (KOA) is the most common form of arthritis, causing disability and impaired quality of life especially in the elderly. Sri Lankan traditional medicine (STM) is widely used to treat OA, but no clinical trial evaluated on STM regimens for KOA to discuss their safety and efficacy in the treatment. The aim of this study is to compare the efficacy and safety of STM regimen for KOA in comparison to recommended conventional pain management therapy over a period of 8 weeks on relieving the condition.

Acute and Subchronic Oral Safety Profiles of the Sudarshana Suspension.

powder (SP) is an Ayurvedic preparation, which contains 53 herbal ingredients along with 50% of and is clinically used with bees honey. This study was aimed to determine the safety profile of the SP, and its novel preparation Sudarshana suspension (SS) on male Wistar rats and tolerance studies were conducted for healthy adult volunteers. Acute and subacute toxicity studies of the SS and hot water extract of SP were assessed in Wistar rats by observing the general behavior, analyzing biochemical and haematological parameters, and pathological observation.

Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial.

Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient's quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice.

Comparative Phytochemical Analysis and Antioxidant Activities of Tamalakyadi Decoction with Its Modified Dosage Forms.

Background And Objective: Tamalakyadi decoction (TD) is a classical formulation mentioned in authentic traditional medicine text Sarasankshepaya under nasal diseases and used as a remedy for allergic rhinitis. It consists of 12 plant ingredients. Decoction preparations are widely used in Sri Lankan traditional system and considered effective and safe for treating many disorders.

Evaluation of the and Antioxidant Potentials of Powder.

powder (SP) is one of the most effective Ayurveda powder preparations for paediatric febrile conditions. The objective of the present study was to evaluate the and antioxidant potentials of SP. The antioxidant effects were evaluated using ABTS radical cation decolourization assay where the TROLOX equivalent antioxidant capacity (TEAC) was determined.

Inhibitory action on the production of advanced glycation end products (AGEs) and suppression of free radicals in vitro by a Sri Lankan polyherbal formulation Nawarathne Kalka.

Background: Advanced glycation end products (AGEs) and free radicals are inflammatory mediators and are implicated in many diseases such as diabetes, cancer, rheumatoid arthritis etc. Multi targeted poly herbal drug systems like Nawarathne Kalka (NK) are able to quench the overall effect of these mediators as they contain good combinations of phytochemicals that have least side effects in contrast to modern medicinal drugs. The objectives of this study were to evaluate phytochemical composition, free radical scavenging activity, cytotoxicity and the inhibitory action on the formation of AGEs by aqueous extract of NK.

Effect of Sri Lankan traditional medicine and Ayurveda on Sandhigata Vata (osteoarthritis of knee joint).

Reported case was a 63-year-old female with end-stage osteoarthritis (OA) (Sandhigata Vata) of the left knee joint accompanied by exostoses. Radiology (X-ray) report confirmed it as a Kellgren-Lawrence grade III or less with exostoses. At the beginning, the Knee Society Rating System scores of pain, movement and stability were poor, and function score was fair.

Functional herbal food ingredients used in type 2 diabetes mellitus.

From many reports it is clear that diabetes will be one of the major diseases in the coming years. As a result there is a rapidly increasing interest in searching new medicines, or even better searching prophylactic methods. Based on a large number of chemical and pharmacological research work, numerous bioactive compounds have been found in functional herbal food ingredients for diabetes.

Anti-inflammatory effects of Clematis chinensis Osbeck extract(AR-6) may be associated with NF-κB, TNF-α, and COX-2 in collagen-induced arthritis in rat.

The root of Clematis chinensis Osbeck has been used widely in rheumatoid arthritis in Chinese traditional medicine, and AR-6 is a triterpene saponin isolated from it. In this present study, we investigated the in vivo effects of oral AR-6 in chronic rat with collagen-induced arthritis (CIA) and possible molecular mechanism. CIA was induced by immunizing 56 female Sprague-Dawley (SD) rats with chicken typeIIcollagen (CII).

Ex vivo and in vivo effect of Chinese herbal pill Yi Shen Juan Bi (YJB) on experimental arthritis.

Aim Of This Study: Chinese herbal pill Yi Shen Juan Bi (YJB), which is a compound herbal drug, has traditionally been used as an anti-rheumatic drug in Chinese local clinics. Thus, we investigated the therapeutic effect of the YJB in rheumatoid arthritis (RA), using Freund's complete induced adjuvant arthritis (AA) in rat model.

Methods: For that purpose, macrophage derived cytokine tumor necrosis factor alpha (TNF-α) and interleukin-1 (IL-1) were measured in ex vivo by enzyme linked immunosorbent assay (ELISA).

Immunomodulatory activity of a Chinese herbal drug Yi Shen Juan Bi in adjuvant arthritis.

Objective: To investigate the immunomodulating mechanisms of a Chinese herbal medicine Yi Shen Juan Bi (YJB) in treatment of adjuvant arthritis (AA) in rats.

Materials And Methods: Levels of serum tumor necrosis factor alpha (TNF-alpha) and interleukin-1beta (IL-1beta) were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Expression of TNF-alpha mRNA and IL-1beta mRNA in synovial cells was measured with the semi-quantitative technique of reverse transcription-polymerase chain reaction (RT-PCR), while caspase-3 was examined by western blot analysis.