Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03506919
Status:
UNKNOWN
Last Update Posted:
2018-04-24
First Post:
2018-01-12
Brief Title:
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis
Sponsor:
Shifa Ul Mulk Memorial Hospital
Organization:
Shifa Ul Mulk Memorial Hospital
Study Overview
Official Title:
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine Arthitec 1 and Arthitec 2 With Allopathic Medicine for the Management of Arthritis
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to develop two poly herbal capsule formulations for arthritis through granulation and conduction of their clinical trial in order to achieve quality efficacy and safety Arthritis is a chronic disease of unknown cause An inflammatory disease of the synovium it results in pain stiffness swelling deformity and eventually loss of function in the joints Despite early detection current treatment medications are limited in their efficacy and are frequently toxic Many patients look for complementary and alternative medicine CAM options in coping with this debilitating disease Research has indicated that people suffering from chronic pain as in arthritis and those dissatisfied with current treatment are very likely to seek alternative treatments and an estimated 60-90 of persons with arthritis use complementary and alternative medicines Among the most widely used treatments are chiropractic and herbal therapies This growing interest in alternative medical practices clearly indicates the need for more thorough investigation into the safety and efficacy of herbal medicine Thousand years of traditional use can provide us with valuable guidelines to the selection preparation and application of herbal formulation To be accepted as viable alternative to modern medicine the same vigorous method of scientific and clinical validation must be applied to prove the safety and effectiveness of a therapeutical product
Detailed Description:
Although there are more than 100 different kinds of arthritis the three most common are gout osteoarthritis OA and rheumatoid arthritis RAGout occurs in response to the presence of monosodium urate MSU crystals in joints bones and soft tissues and is usually treated by non-steroidal anti-inflammatory drugs NSAIDs oral or intravenous colchicines and oral intravenous or intraarticular glucocorticoids All these drugs can abort acute attacks but they also may have severe side effects OA results from articular cartilage failure induced by a combination of genetic metabolic biochemical and biomechanical factors OA is normally treated with analgesics such as acetaminophen and opioids NSAIDs and intraarticular therapies such as glucocorticoids and hyaluronans
In RA 75 of the sufferers are women suggesting the importance of hormones in the etiology of the disease Smoking and stress are also thought to contribute to this disease which is characterized by joint stiffness and swelling often in a symmetrical pattern on both sides of the body The goals of management of patients with RA are to control pain and swelling delay disease progression minimize disability and improve quality of life For pain control and swelling treatment includes analgesics such as acetaminophen and opioids NSAIDs and intra-articular therapies such as glucocorticoids In addition disease modifying anti-rheumatic drugs DMARDs are used to modify the clinical and radiological course of RA Examples include methotrexate MTX sulfasalazine leflunomide hydroxychloroquine and newer therapies such as anti-tumor necrosis factor TNF-a therapy etanercept infliximab and adalimumab anti-CD20 therapy rituximab and abatacept However all of these agents are associated with numerous side effects Promising evidence has been found for the effective use of some herbal preparations in the treatment of arthritis Furthermore evidence suggesting that some herbal preparations reduce consumption of non-steroidal anti-inflammatory drugs It has been evident that some herbal preparations Tripterygium wilfordii Hook F monotherapy is not inferior then methotrexate and in combination with methotrexate showed better result than alone In addition adverse effect associated with trials of herbal preparation for arthritis is not only fewer but also minor Evidence-based complementary and alternative medicine treatments are remarkably successful in addressing not only chronic but acute health issues as well It is strongly perceived that different complementary and alternative medicine treatments exerts their healing potential by influencing immune system
In RA 75 of the sufferers are women suggesting the importance of hormones in the etiology of the disease Smoking and stress are also thought to contribute to this disease which is characterized by joint stiffness and swelling often in a symmetrical pattern on both sides of the body The goals of management of patients with RA are to control pain and swelling delay disease progression minimize disability and improve quality of life For pain control and swelling treatment includes analgesics such as acetaminophen and opioids NSAIDs and intra-articular therapies such as glucocorticoids In addition disease modifying anti-rheumatic drugs DMARDs are used to modify the clinical and radiological course of RA Examples include methotrexate MTX sulfasalazine leflunomide hydroxychloroquine and newer therapies such as anti-tumor necrosis factor TNF-a therapy etanercept infliximab and adalimumab anti-CD20 therapy rituximab and abatacept However all of these agents are associated with numerous side effects Promising evidence has been found for the effective use of some herbal preparations in the treatment of arthritis Furthermore evidence suggesting that some herbal preparations reduce consumption of non-steroidal anti-inflammatory drugs It has been evident that some herbal preparations Tripterygium wilfordii Hook F monotherapy is not inferior then methotrexate and in combination with methotrexate showed better result than alone In addition adverse effect associated with trials of herbal preparation for arthritis is not only fewer but also minor Evidence-based complementary and alternative medicine treatments are remarkably successful in addressing not only chronic but acute health issues as well It is strongly perceived that different complementary and alternative medicine treatments exerts their healing potential by influencing immune system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None