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Clinical Efficacy and Mechanism of Xiangbitong Granule and Decoction in Treating Cervical Spondylosis with Wind-cold-dampness Type

Clinical Efficacy and Mechanism of Xiangbitong Granule and Decoction in Treating Cervical Spondylosis with Wind-cold-dampness Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000590
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Cervical Spondylosis

Interventions

Xiangbitong Decoction(standard dosage) Group:Xiangbitong Decoction(standard dosage)
Xiangbitong Granule(high dosage) Group:Xiangbitong Granule(standard dosage)
Xiangbitong Granule(low dosage) Group:Xiangbitong Granule(low dosage)
Xiangbitong Granule(standard dosage) Group:Xiangbitong Granule(standard dosage)

Sponsors

GuangDong Second Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet Western medicine diagnosis and TCM syndrome type diagnosis; (2) Age 25~65 years old; (3) The course of the disease is 1 month ~ 1 year; (4) VAS score= 4 points; (5) the participants sign the informed consent and process of obtaining informed consent is in accordance with the provisions of Good Clinical Practice (GCP).

Exclusion criteria

Exclusion criteria: (1)Individuals who have shown no response to formal non-surgical therapies after a duration of six months. (2)Patients with abnormal imaging findings but without clinical symptoms of cervical spondylopathy or those whose imaging studies reveal severe cervical deformities tuberculosis tumors etc. (3)Patients suffering from osteoporosis metabolic disorders or debilitating diseases or those with serious primary conditions. (4)Patients exhibiting impaired consciousness or speech disorders. (5)Individuals with a history of using sedative-hypnotics opioid analgesics or alcohol abuse. (6)Long-term users of anticoagulants such as warfarin or aspirin or those with coagulation function abnormalities. (7)Women who are planning to conceive currently pregnant breastfeeding or menstruating. (8)Participants who have received other treatments that could affect this study within the past week. (9)Individuals with incomplete examination data or those unable to comply with examinations and treatments. (10)Patients with allergies (specifically to two or more food items or medications) or allergies to any components of the study medication. Any participant meeting one or more of the ten criteria listed above will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
McGill Pain Questionnaire(MPQ);ROS SOD MDA PGE2 and NGF in serum;Visual Analogue Scale;Neck Disability Index;Traditional Chinese Medicine(TCM) effective rate;

Secondary

MeasureTime frame
Cervical Motion;Traditional Chinese Medicine(TCM) syndrome score;The World Health Organization Quality of Life (WHOQOL)-BREF;

Countries

China

Contacts

Public ContactFan Dehui

GuangDong Second Traditional Chinese Medicine Hospital

1317073040@qq.com13246435796

Outcome results

None listed

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