Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
Bibliographic record
Abstract
Hyo-Rim Jo,1 Yong-Gyun Kim,2 Won-Suk Sung,1 Kyoung Sun Park,3 Yoon Jae Lee,4 Sun Young Cho,5 Byung-Kwan Seo,6 Young-Ee Kwon,2 Eun-Jung Kim1 1Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea; 2Central Research Institute, Samik Pharmaceutical Company LTD., Incheon, Republic of Korea; 3Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 4Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Korea; 5IntegroMedLab Company Ltd., Seoul, Republic of Korea; 6Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Republic of KoreaCorrespondence: Eun-Jung Kim, Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, 268, Buljeong-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, Tel +82-31-710-3719, Fax +82-31-710-3780, Email hanijjung@naver.comPurpose: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in combination with standard treatment and estimate an effective dose for treating PHN.Patients and Methods: This is a protocol for a randomized, placebo-controlled, double-blind, multicenter trial. A total of 90 eligible participants with PHN will be recruited from three hospitals and randomly allocated to high-dose group, low-dose group, or placebo group in a 1:1:1 ratio. The trial will involve a 6-week oral administration of SIKD1977/placebo, and a 1-week follow-up period. The primary outcome will be the weekly average change in average daily pain score (ADPS) from baseline to the end of treatment. The secondary outcomes will include the weekly average changes in ADPS from baseline to week 2, 4, and 7, differences in Short-Form McGill Pain Questionnaire, Visual analogue scale, 5-level EuroQol-5 dimensions, Patient Global Impression of Change, and consumption of rescue drugs. All adverse events will be assessed during the trial.Conclusion: This study will provide evidence for the efficacy and safety of SIKD1977, and an effective dose for PHN.Trial Registration: This protocol has been registered in the Clinical Research Information Service with the identification code KCT0007939.Keywords: postherpetic neuralgia, herbal medicine, SIKD1977, Sogeonjungtang, randomized controlled trial, protocol
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.026 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".