| CTRI Number |
CTRI/2019/02/017690 [Registered on: 15/02/2019] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to find out Effectiveness of Dalbergia sissoo extract (Dalzbone capsules) in femur fracture healing. |
|
Scientific Title of Study
|
A randomized single blind, placebo control clinical study to evaluate the efficacy of Dalbergia sissoo extract (Dalzbone capsule) in healing of diaphyseal fracture of femur |
| Trial Acronym |
DSFFCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punam Sawarkar |
| Designation |
Assistant professor |
| Affiliation |
Mahatma Gandhi Ayurveda college hospital and Research centre |
| Address |
Department of panchakarma, Mahatma Gandhi Ayurveda college hospital and Research centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Assistant professor |
| Affiliation |
Mahatma Gandhi Ayurveda college hospital and Research centre |
| Address |
Department of panchakarma, Mahatma Gandhi Ayurveda college hospital and Research centre Salod Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Assistant professor |
| Affiliation |
Mahatma Gandhi Ayurveda college hospital and Research centre |
| Address |
Department of panchakarma, Mahatma Gandhi Ayurveda college hospital and Research centre Salod Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| PHARMANZA HERBAL PVT. LTD.
Plot No. 214, Borsad-Tarapur Road,
Near Dharmaj Cross Road, At. KANIYA-388435
Tal. Petlad, Dist. Anand, Gujarat.
|
|
|
Primary Sponsor
|
| Name |
Pharmanza Herbal Pvt Ltd |
| Address |
Plot No. 214, Borsad-Tarapur Road,
Near Dharmaj Cross Road, At. KANIYA-388435
Tal. Petlad, Dist. Anand, Gujarat.
|
| Type of Sponsor |
Other [Herbal Extract manufacturing 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 |
| DrPunam Sawarkar |
Acharya Vinoba Bhave Rural Hospital of Datta meghe medical institute |
orthopedic department
Wardha
MAHARASHTRA |
9860667023
drsuple.punam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Datta meghe institute of medical sciences. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Placebo capsules |
Capsules of 300mg of dextrin;
One capsule twice a day after food for the period of six months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Restoration of functional motility confirmed by clinical assessment.
2. Radiological healing and biochemical marker analysis |
0 week, 2 week, 6 week, 12 week, 16 week and 24 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiological healing and biochemical marker analysis |
0 week, 2 week, 6 week, 12 week, 16 week and 24 week. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to evaluate efficacy of Dalbergia sissoo standardized extract in accelerating healing of diaphyseal fracture of femur. This study is expected to benefit the fracture patients in terms of reducing their morbidity, decreasing the period of immobilization and suffering, hastening the recovery process, leading to the early weight bearing, mobility, ambulation and return to the normal health. 60 subjects will be divided into 2 groups (30 subjects/ group), one group will receive Dalbergia sissoo extract capsules (one capsule twice a day) and another group will receive placebo capsules ( one capsule twice a day). the trial medicines will be given to patient with their ongoing standard treatment for fracture. Patient has to visit study site from the screening visit to the end of study at the interval of O week, 2 week, 6 week, 12 week, 16 week and 24 week and undergo clinical, radiological and hematological evaluation.
|