CLINICAL TRIALS PROFILE FOR PENTOXIFYLLINE
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505(b)(2) Clinical Trials for Pentoxifylline
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Indication | NCT05387187 ↗ | Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease | Not yet recruiting | Taipei Medical University Hospital | Phase 2/Phase 3 | 2022-06-01 | The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety. The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine. |
| OTC | NCT06016452 ↗ | A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma | Recruiting | Bhabha Atomic Research Centre (BARC) | Phase 2 | 2023-11-13 | Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC). |
| OTC | NCT06016452 ↗ | A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma | Recruiting | Tata Memorial Centre | Phase 2 | 2023-11-13 | Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC). |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Pentoxifylline
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000579 ↗ | Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1994-09-01 | The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented. |
| NCT00000646 ↗ | Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS | Completed | Hoechst Marion Roussel | Phase 1 | 1969-12-31 | To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity. |
| NCT00000646 ↗ | Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 1969-12-31 | To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity. |
| NCT00001437 ↗ | Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis | Completed | National Cancer Institute (NCI) | Phase 2 | 1995-06-01 | After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response. |
| NCT00001877 ↗ | Treatment of Pulmonary Sarcoidosis With Pentoxifylline | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 | 1999-02-01 | Sarcoidosis is a disease most commonly affecting the lungs, but it can also involve lymph nodes, skin, liver, spleen, eyes, bones, and glands. The cause of the disease is unknown. When it occurs it can produce an inflammatory reaction leading to irreversible organ damage and disability. In sarcoidosis granulomas can form in various organs (primarily lung) which can lead to its dysfunction. Granuloma is formed by clusters of inflammatory cells. The formation of these granulomas is influenced by the release of a substance called TNF-alpha (tumor necrosis factor alpha) which is found in some white blood cells. A drug known as pentoxifylline (POF) is known to markedly reduce the release of TNF-alpha. The standard medical treatment for sarcoidosis is steroid therapy. However, steroid therapy is associated with significant side effects and often must be stopped. Unfortunately, some of these patients can relapse when the steroid therapy is discontinued. Because of this, researchers are interested in finding alternative therapies for the treatment of sarcoidosis. This study will evaluate the effectiveness of giving POF to patients with sarcoidosis currently taking steroids. Researchers will compare the results between patients taking steroids with pentoxifylline and those patients taking steroids alone. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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