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Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis

Primary Purpose

Treatment of Arthritis

Status
Unknown status
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Allopurinol
Sponsored by
Shifa Ul Mulk Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Arthritis

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients suffering from Arthritis

Exclusion Criteria:

  • Patients with Hypertension, Cardiovascular disorders and Kidney disorders were excluded

Sites / Locations

  • clinical trial was conducted in Bahawalpur, and RawalpindiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arthitec 1

Arthitec 2

Arm Description

Outcomes

Primary Outcome Measures

Reduction in Serum Uric Acid level
Reduction in Serum Uric Acid level will be monitored after 8 weeks. Increase level of Serum Uric acid is the major cause of Gouty arthritis which is more prevalent in South-Asian countries.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
April 13, 2018
Sponsor
Shifa Ul Mulk Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03506919
Brief Title
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis
Official Title
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine Arthitec 1 and Arthitec 2 With Allopathic Medicine for the Management of Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Ul Mulk Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (RA).Gout 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthitec 1
Arm Type
Experimental
Arm Title
Arthitec 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems
Primary Outcome Measure Information:
Title
Reduction in Serum Uric Acid level
Description
Reduction in Serum Uric Acid level will be monitored after 8 weeks. Increase level of Serum Uric acid is the major cause of Gouty arthritis which is more prevalent in South-Asian countries.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients suffering from Arthritis Exclusion Criteria: Patients with Hypertension, Cardiovascular disorders and Kidney disorders were excluded
Facility Information:
Facility Name
clinical trial was conducted in Bahawalpur, and Rawalpindi
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
062
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Asif, Ph.D
Phone
923346911256
Email
doctor.asif101@gmail.com
First Name & Middle Initial & Last Name & Degree
Muhamamd Bilal, M. PHil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis

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