NCT05665777

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

December 18, 2022

Last Update Submit

July 5, 2023

Conditions

Chronic Pharyngolaryngitis (Disorder)

Outcome Measures

Primary Outcomes (2)

  • The resolution rate of the clinical symptoms of CP

    Measure the resolution rate of the clinical symptoms at week 8. According to the "Guiding Principles for Clinical Research of Chinese Medicines", the degree of clinical symptom is divided into 4 grades: asymptomatic, mild symptom, moderate symptom, and severe symptom, with a score of 0\~3.

    8 weeks

  • Improvement of laryngeal signs

    Observe the improvement of laryngeal signs via Flexible nasopharyngolaryngoscopy examination

    8 weeks

Secondary Outcomes (19)

  • Complete remission rate of Globus

    8 weeks

  • Complete remission rate of Globus symptom

    16 weeks

  • Visual analogue scale (VAS) of Globus symptom

    8 weeks

  • Visual analogue scale (VAS) of Globus symptom

    16 weeks

  • Change of Numeric rating scale of sore throat

    8 weeks

  • +14 more secondary outcomes

Study Arms (2)

Active treatment (Qingyan Lihou Decoction)

EXPERIMENTAL

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

Drug: Qingyan Lihou Decoction

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Qingyan Lihou DecoctionDRUG

Chinese medicine granules

Also known as: Active treatment
Active treatment (Qingyan Lihou Decoction)
PlaceboOTHER

Placebo granules

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Zhixiu Lin

    Hong Kong Institute of Integrative Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476louislo@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2022

First Posted

December 27, 2022

Study Start

March 30, 2023

Primary Completion

January 31, 2025

Study Completion

July 31, 2025

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)