Effect of Gargle Containing Honeysuckle and Semen Oroxyli
Primary Purpose
Obstructive Sleep Apnea, Complication, Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
honeysuckle and semen oroxyli solution
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patients who had undergone elective UPPP during the period of April 2019 to January 2022
Exclusion Criteria:
- 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.
Sites / Locations
- Hebei Hospital of traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment group
control group
Arm Description
Outcomes
Primary Outcome Measures
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).
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)
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).
Comparison of GGI-I score in two groups
The treatment group performed a lower GGI-I score than control group (P < 0.001)
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)
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05535179
First Posted
September 6, 2022
Last Updated
September 8, 2022
Sponsor
Hubei Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05535179
Brief Title
Effect of Gargle Containing Honeysuckle and Semen Oroxyli
Official Title
The Application of Gargle Containing Honeysuckle and Semen Oroxyli to Reduce the Pain and Complications After Uvulopalatopharyngoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Complication, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
honeysuckle and semen oroxyli solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of resting throat pain in two groups
Description
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).
Time Frame
1 week and 2 weeks after UPPP
Title
Comparison of swallowing throat pain in two groups
Description
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)
Time Frame
12 h, 1 week and 2 weeks after surgery
Title
Comparison of changes in VAS scores between the two groupd for both resting and swallowing throat pain
Description
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).
Time Frame
week 0 to week 2
Title
Comparison of GGI-I score in two groups
Description
The treatment group performed a lower GGI-I score than control group (P < 0.001)
Time Frame
week 0 to week 2
Title
Comparison of total complication rates in two groups
Description
No deaths occurred within the 2-week postoperative period. The total complication rates between the 2 groups was not significantly different (P = 0.071)
Time Frame
2 weeks after surgery
Title
Comparison of post-operative wound infection or wound bleeding between two groups
Description
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.
Time Frame
2 weeks after surgery
Title
Comprision of the levels of hs-CRP, hemoglobin, neutrophil% and WBC between the 2 groups
Description
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).
Time Frame
12 h after surgery and 1 week after sugery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who had undergone elective UPPP during the period of April 2019 to January 2022
Exclusion Criteria:
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.
Facility Information:
Facility Name
Hebei Hospital of traditional Chinese Medicine
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
12. IPD Sharing Statement
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Effect of Gargle Containing Honeysuckle and Semen Oroxyli
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