A clinical study to evaluate efficacy of Dalzbone capsules in fracture healing of long bone fracture of leg

Phase 2

Completed

• Conditions: long bone fracture of leg

• Registration Number: CTRI/2015/06/005850
• Lead Sponsor: Pharmanza Herbal Pvt Ltd

Brief Summary

This is an open label, non randomized, single arm clinical trial. This trial is aimed to evaluate efficacy of Dalzbone capsule in healing of long bone fractures of leg. Total 20 patients with long bone fracture of leg will be recruited in this trial within 0-5 days of internal or external fixation of their fractures. Patients will be given one capsule of Dalzbone three times in a day for 2 months. Dalzbone is FDA approved single herb extract from Pharmanza Herbal Pvt. Ltd. Each capsule of Dalzbone contains 200mg of Dalbergia sissoo(Shisham) leaf extract. The clinical and radiological assessment of the patients will be done at baseline, 4th week, 6th week and 8th week. The data will be recorded and used for publication.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-06
• Last Update Posted: 2016-12-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Radiologically diagnosed traumatic, simple as well as closed long bone fracture of Arms and leg.
• Fractures with internal fixation.
• Willing to give inform consent.
• 0-5 days from the incident of fracture.

Exclusion Criteria

• Pathological fracture.
• Fracture patients with diabetes.
• Pregnant and breast feeding women.
• History of allergy to herbal medicines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fracture union confirmed by radiological assessment	at baseline after four week after six week and after eight week

Secondary Outcome Measures

Name	Time	Method
Restoration of functional motility confirmed by clinical assessment	at baseline after four week after six week and after eight week

Trial Locations

Locations (1)

Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik; 🇮🇳 Nashik, MAHARASHTRA, India

Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik

🇮🇳Nashik, MAHARASHTRA, India

Dr Pankaj Prabhakar Dixit

Principal investigator

sanshodhanayusevansk@gmail.com