Senile osteoporotic fracture
Conditions
Interventions
Experimental group:Treatment with Spleen and Kidney Formula (Compound Granules) was given, to be taken orally at a dose of 2 sachets twice a day, 30 minutes after meals with warm water. To be taken co
Control group:Treatment was given in the form of Spleen and Kidney Formula Mock, to be taken orally at a dose of 2 sachets twice a day, 30 minutes after meals with warm water. Take continuously for 3
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria and inclusion criteria of the 2017 edition of the Guidelines for the diagnosis and treatment of primary osteoporosis and the fourth edition of Practical Orthopaedics edited by Xu Shaoting and the twelfth edition of Campbell's Orthopaedic Surgery in Traumatic Orthopaedics translated by Wang Yan: (1) History of hip trauma such as car accident, sprain or bruise; (2) Clinical symptoms and signs: pressure pain at the greater trochanter of the affected limb (ii) clinical symptoms and signs: pressure pain at the greater trochanter of the affected limb, positive longitudinal percussion pain, bone rubbing sound or bone rubbing sensation can be felt in the affected limb or is not obvious, most of the affected limbs have internal retraction, shortening and external rotation deformity. (3) Imaging manifestations: X-ray or CT shows obvious signs of fracture between the femoral ridge; (4) T value <= -2.5 SD for osteoporosis); in line with the diagnostic criteria of the Expert Consensus on Prevention and Treatment of Primary Osteoporosis in Chinese Medicine (2015) for the Chinese medicine syndrome of spleen and kidney yang deficiency (i.e. main symptom: cold pain in the waist and knee, loose stools with little food. Secondary symptoms: soreness and weakness of the waist and knees, weakness in walking on both knees, stooping, aversion to cold and warmth, abdominal distension, white face, pale, fatty tongue, white smooth coating, sluggish pulse, etc. In the diagnosis of the symptoms, cold pain in the waist and knees and loose food and stool are the necessary symptoms, and two other secondary symptoms and a supporter of the tongue and pulse can be diagnosed. 2. Patients given PFNA internal fixation for intertrochanteric fractures of the femur. 3. Those who were able to walk independently without crutches before the injury 4. Signed informed consent and assurance of compliance with the trial. 5. Patients who are not receiving any other treatment options.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic or hypersensitive to the test drug or who have had serious adverse reactions to the use of the test drug. 2. Patients with hypercalcemia, hyperuricemia, renal calculi and chronic renal insufficiency. 3. Patients with secondary osteoporosis such as hyperparathyroidism, osteochondrosis, rheumatoid arthritis, gout, multiple myeloma and other secondary osteoporosis; patients with various endocrine diseases (e.g. Cushing's disease, hyperthyroidism, hyperparathyroidism, hypothyroidism, diabetes mellitus, etc.). 4. Patients with tumours or cancer; patients with manic, depressive or other psychiatric disorders; women who are breastfeeding or pregnant. 5. Patients with a history of infectious diseases such as tuberculosis, hepatitis B, HIV carriers and other infectious diseases 6. Combination of poorly controlled medical conditions such as diabetes mellitus, hypertension and hyperlipidaemia. 7. History of opioid analgesics, sedative-hypnotics and alcohol abuse 8. Patients with severe primary diseases of the heart, brain, liver, kidney, haematopoietic system, endocrine system, etc. 9. Patients with open fractures with soft tissue defects or infections. 10.Patients with geriatric pathological fractures caused by bone disease (benign or malignant tumours, tuberculosis, osteomyelitis, endocrine metabolic factors) or combined with fractures of other sites. 11. Patients with poor compliance and unable to meet follow-up requirements. 12. Patients whose condition is so critical that it is difficult to make a definitive judgement on the effectiveness and safety of the new drug. 13. Patients currently taking any other Chinese herbal medicine or preparations containing Chinese herbal ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| X-Ray Fracture Healing Score;Clinical healing rate at three months after fracture; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Visual Pain Score;Hip Function Score;Bone density testing;Bone metabolism indicators; | — |
Countries
China
Contacts
Public ContactTang Dezhi
Shanghai University of Traditional Chinese Medicine
Outcome results
None listed