| CTRI Number |
CTRI/2015/06/005850 [Registered on: 03/06/2015] Trial Registered Prospectively |
| Last Modified On: |
24/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate efficacy of Dalzbone capsules in fracture healing of long bone fracture of leg |
|
Scientific Title of Study
|
Non randomized, open label clinical study to evaluate efficacy of Dalzbone capsules in fracture healing of long bone fracture of leg |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Prabhakar Dixit |
| Designation |
Asso Professor |
| Affiliation |
Ayurved Seava Sanghs Ayurved Mahavidyalaya Nashik |
| Address |
Department of Shalyatantra, Ayurved Seava Sanghs Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9011045371 |
| Fax |
0253-2517170 |
| Email |
drpankajpdixit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmol Deshmukh |
| Designation |
R&D Executive |
| Affiliation |
Pharmanza Herbal Pvt. Ltd. |
| Address |
Pharmanza Herbal Pvt. Ltd. Plot No. 214 Borsad-Tarapur Road, Vadadla Patia Kaniya-388435 Tq. Petlad, Dist.Anand Gujrat.
Anand
GUJARAT
388435
India
Anand
GUJARAT
388435
India |
| Phone |
9898652936 |
| Fax |
|
| Email |
rd@pharmanzaherbals.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAmol Deshmukh |
| Designation |
R&D Executive |
| Affiliation |
Pharmanza Herbal Pvt. Ltd. |
| Address |
Pharmanza Herbal Pvt. Ltd. Plot No. 214 Borsad-Tarapur Road, Vadadla Patia Kaniya-388435 Tq. Petlad, Dist.Anand Gujrat.
Anand
GUJARAT
388435
India
Anand
GUJARAT
388435
India |
| Phone |
9898652936 |
| Fax |
|
| Email |
rd@pharmanzaherbals.com |
|
|
Source of Monetary or Material Support
|
| Pharmanza Herbal Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Pharmanza Herbal Pvt Ltd |
| Address |
Borsad Tarapur road, Near Darmoj crossroad,
Vadadla Patiya, Kaniya-388435, Tq. Petlad, Dist Anand, Gujrat.
|
| Type of Sponsor |
Other [Herbal Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Prabhakar Dixit |
Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik |
Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik. Ganeshwadi, Panchavati, Nashik -422003
Nashik
MAHARASHTRA |
0253-2512097
0253-2512097
sanshodhanayusevansk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, A.S.S. Ayurved Mahavidyalaya Nashik. Ganeshwadi, Panchavati, Nashik (Maharashtra) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
long bone fracture of leg, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Dalzbone |
each capsule of Dalzbone contains standardized extract of leaves of Dalbergia sissoo (shisham)- 300mg
Dosage: two capsule 2 times a day
Route of administration: Oral
Duration of therapy: 2 months |
| Comparator Agent |
no drug |
there is no comparator drug |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-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
|
|
| ExclusionCriteria |
| Details |
-Pathological fracture.
-Fracture patients with diabetes.
-Pregnant and breast feeding women.
-Patients with end organ failure.
-History of allergy to herbal medicines. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fracture union confirmed by radiological assessment |
at baseline after four week after six week and after eight week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Restoration of functional motility confirmed by clinical assessment |
at baseline after four week after six week and after eight week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
data obtained in this study will be used to publish in peer reviewed journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |