Health Condition 1: S723- Fracture of shaft of femur
Conditions
Interventions
Intervention1: Dal-Z-Bone capsules: Capsules of 300mg of Dalbergia sissoo leaves extract
one capsule twice a day after food for the period of six months
Control Intervention1: Placebo: Capsules of 300mg of dextrin
Control Intervention2: Placebo capsules: Capsules of 300mg of dextrin
One capsule twice a day after food for the period of six months.
Sponsors
Pharmanza Herbal Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Radiologically diagnosed traumatic diaphyseal fracture of femur bone indifferent of compound, comminuted, closed or open fracture with surgical intervention. 2. Willing to give informed consent. 3. 0-5 days from the incident of fracture.
Exclusion criteria
Exclusion criteria: 1. Pathological fracture. 2. Fracture patients with uncontrolled HTN(Blood Pressure >=140 mmHg or an average Diastolic Blood Pressure >=90 mmHg among those with HTN) or diabetes (Blood Glucose Level > 200 and Fasting Blood Glucose Level > 125 among those with diabetes) 3. Fracture in smokers. 4. Pregnant and breast feeding women. 5. History of allergy to herbal medicines. 6. Patient with renal failure, liver failure and or cardiac failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Restoration of functional motility confirmed by clinical assessment. 2. Radiological healing and biochemical marker analysisTimepoint: 0 week, 2 week, 6 week, 12 week, 16 week and 24 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological healing and biochemical marker analysisTimepoint: 0 week, 2 week, 6 week, 12 week, 16 week and 24 week. | — |
Countries
India
Contacts
Public ContactDr Punam Sawarkar
Mahatma Gandhi Ayurveda college hospital and Research centre
Outcome results
None listed