NCT05370898

The Study of Chinese Medicine for the Treatment of Primary Osteoporosis

Clinical Study of Bugu Shengsui Decoction for the Treatment of Primary Osteoporosis (Kidney Yang Deficiency Syndrome)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and possible mechanism of traditional Chinese medicine in the treatment of primary osteoporosis (Kidney Yang Deficiency Syndrome).It is a randomized, placebo-controlled trial.

Detailed description

The subjects are selected according to the inclusion criteria and exclusion criteria. Using the network random system, 120 subjects who meet the research criteria are randomly divided into control group and experimental group, with 60 cases in each group. Patients in treatment group take the granule of traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Twice a day, in the morning and evening, 30 minutes after meals.The experimental drugs were provided by the pharmacy department of Wangjing hospital, Chinese Academy of traditional Chinese medicine, and the course of treatment was 3 months.The observation time points were before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment. Visual Analogue Score (VAS), Traditional Chinese Medicine（TCM）syndrome score, SF-12 scale and bone metabolism index were used as observation indexes.At the same time, it is planned to determine EphrinB2, EphB4, Runx2 and VEGF in serum by ELISA. Tele-medicine and information management system is established to help achieve follow-up interviews.Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.

Conditions

• Primary Osteoporosis

Interventions

Type	Name	Description
DRUG	Caltrate D	Caltrate D is allowed for basic treatment when the patient is diagnosed with primary osteoporosis (Kidney Yang Deficiency Syndrome).Take it continuously for 3 months.
DRUG	Chinese medicine prescription	The Chinese medicine application prescription is composed of Rhizoma Drynariae 12g, psoralen 10g, dog ridge 10g, medlar 10g, raw oyster 10g, ginseng 6g, Panax notoginseng 3g, Amomum villosum 6g.Patients take 200ml each time, twice a day. Treatment duration are 3 months.
DRUG	Placebo	The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months.

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-01
• Completion: 2023-05-01
• First posted: 2022-05-12
• Last updated: 2022-05-19

Locations

1 site across 1 country: China