Chinese Medicine for Treating Chronic Pharyngolaryngitis

NCT ID: NCT05665777

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2025-07-31

Brief Summary

A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Chronic pharyngolaryngitis. Subjects will be randomized into a treatment group or placebo group for 8 weeks, and then followed by an 8-week post-treatment visit.

Detailed Description

Chronic pharyngolaryngitis (CP), also known as chronic pharyngitis, is defined as the inflammation of the pharynx, which is at the back of the throat. CP is a common disease characterized by dry throat, sore throat, pharyngeal itching, dry cough, and difficulty in swallowing. In Western medicine, common treatment regimens for CP include lozenges, antibiotics, lasers, and cryotherapy. However, the above treatment modalities may not be effective, and the disease is likely to bounce back repeatedly.

Chinese medicine has been used for the treatment of CP for a long time. Many studies have shown that treatment using Chinese herbal medicine is effective in relieving the symptoms of CP.

This study is to evaluate the efficacy and safety of oral Qingyan Lihou Decoction in relieving the clinical symptoms of patients with CP.

Conditions

Chronic Pharyngolaryngitis (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active treatment (Qingyan Lihou Decoction)

It consists of 22 kinds of Chinese medicine as ingredients. It was prepared in granule form.

Group Type: EXPERIMENTAL

Qingyan Lihou Decoction

Intervention Type: DRUG

Chinese medicine granules

Placebo

The placebo medication is composed of starch and an edible pigment and will be matched as closely as possible to the appearance and taste of Qingyan Lihou Decoction granules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo granules

Interventions

Qingyan Lihou Decoction

Chinese medicine granules

Intervention Type: DRUG

Placebo

Placebo granules

Intervention Type: OTHER

Other Intervention Names

Active treatment

Eligibility Criteria

Inclusion Criteria

• 18 years of age or above (Chinese subjects only);
• Persistent symptoms of pharyngitis (sore throat, globus, dry throat, dry cough, throat irritation) for more than 3 weeks;
• Determined to be the following Chinese medicine syndromes by Registered Chinese Medicine Practitioners (RCMPs): Wind-heat invading the upper-jiao, or phlegm heat or Yin deficiency;
• Visual analog scale (VAS) score for pain ≥ 50 mm;
• Numeric rating scale (NRS) ≥ 6; and
• Be able to give voluntary written informed consent.

Exclusion Criteria

• Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
• Concomitant use of steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and immunotherapy within the past week;
• Impaired hematological profile and liver / renal function exceed the upper limit of the reference value by 2 times;
• Known Allergic rhinitis;
• Known Gastroesophageal Reflux Disease (GERD);
• Known cancer or suspected cancer of throat/oesophagus;
• Mechanical obstruction of the throat accountable for the symptoms;
• Known alcohol and/or drug abuse;
• Known allergic history to any Chinese herbal medicines; and
• Subjects who are known pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu Lin

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Institute of Integrative Medicine

Locations

Hong Kong Institute of Integrative Medicine

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Cho Wing Lo

Role: CONTACT

louislo@cuhk.edu.hk

35053476

Facility Contacts

Zhixiu LIN

Role: primary

28733252

Other Identifiers

CP study

Identifier Type: -

Identifier Source: org_study_id