NCT05535179

Effect of Gargle Containing Honeysuckle and Semen Oroxyli

Completed Phase 2 Last updated 10 September 2022

What this trial tests

Phase 2 trial testing honeysuckle and semen oroxyli solution in Obstructive Sleep Apnea in 218 participants. Completed in 31 January 2022.

Timeline

1 April 2019

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	Hubei Hospital of Traditional Chinese Medicine
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	218
Start date	1 April 2019
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	1 location across China

Drugs / interventions tested

• honeysuckle and semen oroxyli solution — full drug profile →

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Complication — all drugs for Complication →
• Pain — all drugs for Pain →

Sponsor

Hubei Hospital of Traditional Chinese Medicine

Who can join

Adults 18 to 60, any sex, with Obstructive Sleep Apnea or Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Surgery All patients included in this study underwent UPPP under general anesthesia with a low-temperature plasma ablation apparatus (PLA-600; Zhongyuan Medical Equipment Co., Ltd.; Shandong, China). Briefly, the surgery was carried out under general anesthesia using a nasal cannula. A 70# low-temperature plasma cutter head was used to perform bilateral epicapsular ablation of the tonsils. Inverted "U" incisions were made on the bilateral soft palate respectively, and the 70# cutter head progressively melted the adipose tissue and other soft tissues in the the veli palatine region. Subsequently, a 55# low-temperature plasma cutter head was used to perform perforation and ablation from between the two mucosal layers of the soft palate to the direction of the hard palate, with 2-3 holes on each side, and each ablation time was 8-12 s.

Treatments Patients in both the 2 groups received amoxicillin sodium suspension every 8 hours for 7 days after UPPP. Except for these drugs, patients in the treatment group were instructed to gargle the suspension solution containing honeysuckle and semen oroxyli (25 mL) for 5 minutes. The solution was given 4 times a day for 2 weeks. The patients in the control group were instructed to gargle normal saline (25 mL) at the same schedule. No NSAIDs were administered unless requested by the patient.

Data collection The post-operative resting throat pain and swallowing throat pain were evaluated at 0 week (12 hours after surgery), 1 week and 2 weeks after UPPP by the patients themselves using a visual analog scale (VAS) based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. Then, the changes of scores from week 0 to week 2 between the 2 groups were compared. The VAS scores related to patient comfort level were also evaluated by patients themselves, with 0 representing very much worse and 10 very much comfort. Furthermore, the researchers who were blinded to the therapeutic regimens evaluated the improvement in postoperative pain of patients within the 2-week postoperative period based on the clinical global impression of improvement (CGI-I score) questionnaire. In this questionnaire, the researchers used a seven-point scale from 1 (very much improved) to 7 (very much worse) to rate the improvement of body pain of the patients (10).

The post-operative complications, such as wound infection and wound bleeding, were collected and analyzed. The baseline characteristics of the patients in 2 groups including age, gender, body mass index (BMI), OSA severity, American Society of Anesthesiologist (ASA) classification and pre-operative complications were also collected. The venous blood was collected at 12 h and 1 week after operation to detect the levels of hs-CRP, hemoglobin, neutrophil% and white blood cell count (WBC).

Statistical analysis The data in this study were analyzed by the SPSS software (version 22.0). Normal distribution quantitative data were described as mean ± SD. The difference between groups were compared by the Student's t test. Non-normal distribution quantitative data were described as median with range and compared with Mann-Whitney U test. Categorical data were described as numbers and percentages and compared using the Chi-square test or Fisher's exact test. P \< 0.05 was considered as statistical significance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The application of gargle containing honeysuckle and semen oroxyli to reduce the pain and complications after uvulopalatopharyngoplasty.
   Ren L, Li J, Miao Z, Yan R, et al · · 2022 · cited 2× · PMID 36324688 · DOI 10.3389/fphar.2022.974233