Chinese Medicine for Treating Chronic Pharyngolaryngitis

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 2

Conditions: Chronic Pharyngolaryngitis (Disorder)

Treatments: Other: Placebo; Drug: Qingyan Lihou Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT05665777

CP study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

74 participants in 2 patient groups, including a placebo group

Active treatment (Qingyan Lihou Decoction)

Experimental group

Description:

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

Treatment:

Drug: Qingyan Lihou Decoction

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo