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Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - cancer pain

Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - cancer pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077238
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-11-06
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain

Interventions

Experimental group with Phlegm-dampness syndrome type cancer pain:Honeysuckle and Baizhi Beverage
Control group with:Honeysuckle and Baizhi Beverage Placebo
Experimental group with Qi deficiency and phlegm dampness syndrome cancer pain:Ginseng and Concha Ostreae Beverage
Control group with Qi deficiency and phlegm dampness syndrome cancer pain:Ginseng and Concha Ostreae Beverage Placebo

Sponsors

Affiliated Hospital of Shandong University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Cancer pain was subject to the following inclusion criteria: (1) 18 = age = 75 years old, gender is not limited; (2) Cancer patients with a clear pathologic diagnosis (conforming to the clinical diagnosis is also acceptable); (3) 4 = NRS = 6, KPS score = 40; (4) Expected survival period of more than 3 months. (5) Good compliance and signing of informed consent before enrollment. (6) Subjects agreed not to participate in other intervention studies during the treatment period. In addition, the following criteria should be met: (1) The diagnostic criteria of cancerous pain and the TCM diagnosis of "phlegm-dampness syndrome" should be met. (2) Those who meet the diagnostic criteria of cancer pain and the TCM diagnostic classification of "Qi deficiency and phlegm dampness syndrome".

Exclusion criteria

Exclusion criteria: (1) Subjects with known or suspected allergies to known components of the study drug. (2) Persons who are unable to understand, read, and complete the Patient Self-Assessment Scale due to their level of knowledge or intelligence. (3) Women of childbearing age who are pregnant, breastfeeding, or inadequately contracepted. (4) Those who have received other treatment or participated in other therapeutic clinical trials within 30 days. (5) Any unstable condition or condition that may jeopardize the safety of the patient and his/her compliance with the study (persons with severe mental illness such as schizophrenia, persons with significant traumatic damage such as surgical treatment within 30 days, persons with comorbidities of severe cardiovascular system diseases, cerebrovascular system diseases, active hepatitis, severe abnormalities of hepatic and renal functions, or other acute life-threatening illnesses). (6) Non-cancer pain (pain related to tumor emergencies such as pathological fracture, infection, visceral obstruction, visceral perforation, etc., surgery, and medically induced pain such as surgery, puncture, chemotherapy, radiotherapy, etc.). (7) Persons judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale for Pain Level (NRS score);Chinese medicine evidence efficacy score;

Countries

China

Contacts

Public ContactLiu Zhaidong

Affiliated Hospital of Shandong University of TCM

15610113386@163.com+86 135 7314 4030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026