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

NCT03506919 | Unknown Phase 1 DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment of Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

Arthitec 1

EXPERIMENTAL

Drug: Allopurinol

Arthitec 2

EXPERIMENTAL

Drug: Allopurinol

Interventions

Allopurinol DRUG

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

Arthitec 1; Arthitec 2

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients suffering from Arthritis

You may not qualify if:

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

Sponsors & Collaborators

• Shifa Ul Mulk Memorial Hospital: lead

Study Sites (1)

clinical trial was conducted in Bahawalpur, and Rawalpindi

Bahawalpur, Punjab Province, 062, Pakistan

RECRUITING

MeSH Terms

Interventions

Allopurinol

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: April 24, 2018
• Study Start: January 1, 2018
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

PA (1)