Effect of Gargle Containing Honeysuckle and Semen Oroxyli

NCT05535179 | Completed Phase 2

• 1 other identifier: HubeiHTCM 001
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Complication; Pain

Outcome Measures

Primary Outcomes (7)

• Comparison of resting throat pain in two groups

  For resting throat pain at 1 week and 2 weeks after UPPP, the VAS scores of the treatment group were much lower than those of the control group (P = 0.033 and P = 0.031, respectively, Table 2). However, the VAS scores for resting throat pain measured at 12 h after UPPP were not significantly different between the 2 groups (P = 0.465).

  1 week and 2 weeks after UPPP

• Comparison of swallowing throat pain in two groups

  For swallowing throat pain, treatment group had much lower VAS scores than control group at 2 weeks after surgery (P \< 0.001). But the 2 groups had similar VAS scores for swallowing throat pain at 12 h and 1 week after surgery (P = 0.414 and 0.732, respectively)

  12 h, 1 week and 2 weeks after surgery

• Comparison of changes in VAS scores between the two groupd for both resting and swallowing throat pain

  The changes of VAS scores for both resting and swallowing throat pain from week 0 to week 2 were significantly higher in treatment group than in control group (P \< 0.001 and P = 0.005, respectively).

  week 0 to week 2

• Comparison of GGI-I score in two groups

  The treatment group performed a lower GGI-I score than control group (P \< 0.001)

  week 0 to week 2

• Comparison of total complication rates in two groups

  No deaths occurred within the 2-week postoperative period. The total complication rates between the 2 groups was not significantly different (P = 0.071)

  2 weeks after surgery

• Comparison of post-operative wound infection or wound bleeding between two groups

  Although the treatment group had less numbers of patients with post-operative wound infection or wound bleeding, the difference between the 2 groups was not statistically significant.

  2 weeks after surgery

• Comprision of the levels of hs-CRP, hemoglobin, neutrophil% and WBC between the 2 groups

  The levels of hs-CRP, hemoglobin, neutrophil% and WBC between the 2 groups at 12 h after surgery were not significantly different. One week after operation, the levels of hs-CRP, Hemoglobin, and WBC in the treatment group were significantly lower than those in the control group (P\<0.05).

  12 h after surgery and 1 week after sugery

Study Arms (2)

treatment group

EXPERIMENTAL

Drug: honeysuckle and semen oroxyli solution

control group

NO INTERVENTION

Interventions

honeysuckle and semen oroxyli solution DRUG

The patients in the treatment group were instructed to gargle the solution containing honeysuckle and semen oroxyli (25 mL) four times a day for 2 weeks.

treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who had undergone elective UPPP during the period of April 2019 to January 2022

You may not qualify if:

• patients with a history of systemic diseases such as severe cardiac and/or pulmonary disorders;
• patients who were unable to cooperate with evaluations;
• patients with severe diabetes;
• patients who had underwent other surgeries in the last 6 months.

Sponsors & Collaborators

• Hubei Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Hebei Hospital of traditional Chinese Medicine

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pain

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: April 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

CN (1)