Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

La medicina ayurvédica ofrece una buena alternativa a la glucosamina y celecoxib en el tratamiento de la artrosis sintomática de rodilla: un estudio doble ciego, aleatorizado controlado de drogas equivalencia.

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Revista Rheumatology (Oxford, England)
Año 2013
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias) 1 Síntesis amplia Síntesis amplias (1 referencia)

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OBJETIVO: demostrar la equivalencia clínica entre dos formulaciones estandarizadas Ayurveda (India) (SGCG y SGC), glucosamina y celecoxib (AINE). MÉTODOS: fórmulas ayurvédicas (extractos de tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), sulfato de glucosamina (2 g al día) y celecoxib (200 mg al día) fueron evaluados en una, paralelos y eficacia aleatorizado, doble ciego, de cuatro brazo, multicéntrico ensayo de la droga equivalencia de 24 semanas de duración. Un total de 440 pacientes elegibles que sufren de artrosis sintomática de rodilla se inscribieron y monitoreada según el protocolo. Las variables de eficacia primaria fueron dolor activa el cuerpo de soporte de peso (escala analógica visual) y el dolor WOMAC modificado y la puntuación de Likert dificultad funcional (por la rodilla y la cadera); los correspondientes a priori rangos de equivalencia eran ± 1,5 cm, ± 2.5 y ± 8.5. RESULTADOS: Las diferencias entre los grupos de intervención para la media de los cambios en las variables de eficacia primaria estaban dentro del rango de equivalencia por intención de tratar y análisis por protocolo. Veintiséis pacientes mostraron una mayor transaminasa glutámico pirúvico en suero asintomática (SGPT) con la función del hígado por lo demás normal; siete pacientes (intervención ayurvédica) se retiraron y SGPT normalizaron después de suspender el medicamento. Otros eventos adversos fueron leves y no se diferencian por la intervención. En general, el 28% de los pacientes se retiraron del estudio. Conclusión: En este estudio controlado de 6 meses de la OA de la rodilla, las formulaciones de Ayurveda (especialmente SGCG) redujo significativamente el dolor de rodilla y la función mejorada de la rodilla y fue equivalente a la glucosamina y celecoxib. El aumento de SGPT inesperada requiere una mayor evaluación de la seguridad. Prueba de registro: Drogas Registro de Ensayos Clínicos y la India, www.ctri.nic.in, CTRI / 2008/091 / 000.063.

Estudio primario

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Un estudio aleatorizado controlado Evaluación exploratoria de estandarizados ayurvédica formulaciones en las rodillas sintomático de la osteoartritis: Un Gobierno de la India Proyecto NMITLI.

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Revista Evidence-based complementary and alternative medicine : eCAM
Año 2011
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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El Proyecto de la artritis multidisciplinar "Iniciativa de Liderazgo en Tecnología de la India nuevo milenio" se llevó a cabo para validar la medicina ayurvédica. Las formulaciones a base de hierbas en uso popular fueron seleccionados por consenso de expertos y se estandarizaron utilizando herramientas modernas. Nuestra estrategia clínica evolucionó a partir de simples evaluaciones exploratorias a los ensayos de medicamentos diseñados estadísticamente mejor alimentados. Los resultados del primer ensayo de la droga se presentan aquí. Cinco formulaciones orales (codificado A, B, C, D y E), con una base común de Zingiber officinale y Tinospora cordifolia, con un máximo de cuatro extractos de plantas, se evaluaron; con placebo y la glucosamina como controles. 245 pacientes que sufren de rodillas OA sintomática fueron distribuidos aleatoriamente en siete brazos (35 pacientes por grupo) de un estudio doble ciego, de eficacia en paralelo, el juicio multicéntrico de la duración de dieciséis semanas. Los grupos emparejados bien al inicio del estudio. No hubo diferencias para los retiros de los pacientes (17,5%) o eventos adversos (EA) de carácter leve. Intención de tratar el análisis de eficacia, demostró que no había diferencias significativas (P <0,05) para el dolor (que soporta el peso) y el cuestionario de WOMAC (función de la rodilla); respuesta al placebo fue alta. Sobre la base de un mejor alivio del dolor, significativa (P <0,05) menos el consumo de analgésicos y un mejor estado de la rodilla, la formulación "C" fue seleccionado para un mayor desarrollo. ensayos de medicamentos de exploración controlados con múltiples brazos de tratamiento se pueden usar para evaluar económicamente formulaciones estandarizadas varios candidatos.

Estudio primario

No clasificado

Comparative efficacy and tolerability of 5-Loxin and AflapinAgainst osteoarthritis of the knee: a double blind, randomized, placebo controlled clinical study.

Revista International journal of medical sciences
Año 2010
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Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

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Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin(®) and Aflapin(®) in the treatment of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN80793440). Sixty OA subjects were included in the study. The subjects received either 100 mg (n=20) of 5-Loxin(®) or 100 mg (n=20) of Aflapin(®) or a placebo (n=20) daily for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. A battery of biochemical parameters in serum, urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin(®) and Aflapin(®) in OA subjects. Fifty seven subjects completed the study. At the end of the study, both 5-Loxin(®) and Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Interestingly, significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin. Corroborating the improvements in pain scores in treatment groups, our in vitro studies provide evidences that Aflapin(®) is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1. Aflapin(®) and 5-Loxin(®) reduce pain and improve physical functions significantly in OA subjects. Aflapin exhibited better efficacy compared to 5-Loxin(®). In comparison with placebo, the safety parameters were almost unchanged in the treatment groups. Hence both 5-Loxin(®) and Aflapin(®) are safe for human consumption.

Estudio primario

No clasificado

A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin for treatment of osteoarthritis of the knee.

Revista Arthritis research & therapy
Año 2008
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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INTRODUCTION: 5-Loxin is a novel Boswellia serrata extract enriched with 30% 3-O-acetyl-11-keto-beta-boswellic acid (AKBA), which exhibits potential anti-inflammatory properties by inhibiting the 5-lipoxygenase enzyme. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the efficacy and safety of 5-Loxin in the treatment of osteoarthritis (OA) of the knee. METHODS: Seventy-five OA patients were included in the study. The patients received either 100 mg (n = 25) or 250 mg (n = 25) of 5-Loxin daily or a placebo (n = 25) for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients. Measurement of a battery of biochemical parameters in serum and haematological parameters, and urine analysis were performed to evaluate the safety of 5-Loxin in OA patients. RESULTS: Seventy patients completed the study. At the end of the study, both doses of 5-Loxin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients. Interestingly, significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, we also noted significant reduction in synovial fluid matrix metalloproteinase-3. In comparison with placebo, the safety parameters were almost unchanged in the treatment groups. CONCLUSION: 5-Loxin reduces pain and improves physical functioning significantly in OA patients; and it is safe for human consumption. 5-Loxin may exert its beneficial effects by controlling inflammatory responses through reducing proinflammatory modulators, and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients. TRIAL REGISTRATION: ( CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN05212803.).

Estudio primario

No clasificado

Evaluation of the efficacy and safety of JT-2000* in Osteoarthritis: a randomized controlled clinical trial.

Autores Khare KD , Khare R , Kolhapure SA
Revista Indian J Clin Pract
Año 2004

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Estudio primario

No clasificado

Clinical evaluation of the efficacy of JT-2000 * in the management of osteoarthritis : A double-blind placebo-controlled trial

Revista Medicine update
Año 2004

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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ABSTRACT Osteoarthritis (OA), degenerative arthritis is one of the most common forms of arthritis. NSAIDs are the preferred choice for the management of OA. However, the use of NSAIDs in OA is causally associated with various short and long term adverse effects. The present study was aimed to evaluate the efficacy and safety of JT-2000, a polyherbal drug, in patients suffering from OA of knee. This was a randomized placebo-controlled clinical trial conducted on 100 patients of either sex, with clinical and radiological evidence of OA of the knee. Patients with established hypertension, renal, hepatic or cardiac failure, on long-term steroid treatment, or with evidence of rheumatoid arthritis and gout were excluded from the study. All the patients were randomized into drug and placebo groups of 50 patients each. A detailed medical history of all patients was recorded and symptomatic evaluation was done using the scoring system followed by clinical, radiological and blood chemistry examination. All patients were followed up for 6 months. The predefined primary outcome measure for efficacy was a decrease in the total sign-and-symptom score at the end of 6 months; secondary outcome measures were short- and long-term safety, assessed by incidence of adverse events, patient compliance to therapy and improvement in laboratory parameters. All adverse events predefined as unrelated, possible and probable, reported by the patients, were recorded. Statistical analysis was done according to intention-totreat principles. The minimum level of significance was fixed at 95% confidence limit and a 2- sided p value of less than 0.05 was considered significant. Patients ranged from 20-80 years and there were thrice as many female as males. No significant changes were observed in any of the biochemical parameters in both groups. The reduction in the mean of number of joints involved in the JT-2000 group was highly significant (t=17.32, p<0.0001), while the results were not significant in the placebo group. (t=1.56, p=0.1208). There was a significant reduction in the average swelling score and pain scores and mean secondary muscle weakness score, in the JT-2000 group compared to the placebo group. At the end of 6 months treatment, patients in the JT-2000 group had a significant reduction in difficulty in climbing, compared to the placebo group. In the JT-2000 group, there was a significant decrease in subchondral sclerosis, osteophytes, cartilage proliferation, fibrosis, synovial fluid viscosity and crystal deposition at the end of 6 months of treatment. The unaltered blood chemistry, liver and renal function parameters suggested long-term safety of the drug. In this study, there was an excellent relief from pain at the end of the therapy and an overall improvement in quality of life of the JT-2000 group. This study indicates that JT-2000 is a more effective and safer alternative for long-term use in the management of mild to moderate OA than NSAIDs.

Estudio primario

No clasificado

Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial.

Revista Phytomedicine : international journal of phytotherapy and phytopharmacology
Año 2003
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Este artículo está incluido en 8 Revisiones sistemáticas Revisiones sistemáticas (8 referencias)

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Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder, which commonly affects the knee joint. Boswellia serrata tree is commonly found in India. The therapeutic value of its gum (guggulu) has been known. It posses good anti-inflammatory, anti-arthritic and analgesic activity. A randomized double blind placebo controlled crossover study was conducted to assess the efficacy, safety and tolerability of Boswellia serrata Extract (BSE) in 30 patients of osteoarthritis of knee, 15 each receiving active drug or placebo for eight weeks. After the first intervention, washout was given and then the groups were crossed over to receive the opposite intervention for eight weeks. All patients receiving drug treatment reported decrease in knee pain, increased knee flexion and increased walking distance. The frequency of swelling in the knee joint was decreased. Radiologically there was no change. The observed differences between drug treated and placebo being statistically significant, are clinically relevant. BSE was well tolerated by the subjects except for minor gastrointestinal ADRs. BSE is recommended in the patients of osteoarthritis of the knee with possible therapeutic use in other arthritis.

Estudio primario

No clasificado

Clinical evaluation of Rumalaya forte in osteoarthrosis

Revista Medicine update
Año 2003

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Estudio primario

No clasificado

Rumalaya Therapy in Rheumatoid Arthritis Osteoarthritis and Periarthritis Shoulder

Autores Sandhu, HS , Kaler, JS
Revista The Antiseptic
Año 1978

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Estudio primario

No clasificado

Rumalaya in osteoarthritis.

Autores Taneja DK , Chara GU (
Revista Antisep
Año 1975

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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