| CTRI Number |
CTRI/2019/03/017955 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
06/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of treatment in Parkinsons disease |
|
Scientific Title of Study
|
Comparison of effectiveness of trihexyphenidyl and levodopa on motor symptoms in Parkinson’s disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lulup Kumar Sahoo |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology, NIMHANS
Department of Neurology
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9583549125 |
| Fax |
|
| Email |
lulupsahoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pramod Kumar Pal |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
NIMHANS
Department of Neurology
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829406 |
| Fax |
|
| Email |
palpramod@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lulup Kumar Sahoo |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
NIMHANS
Department of Neurology
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9583549125 |
| Fax |
|
| Email |
lulupsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Neurology |
| Address |
NIMHANS |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Lulup Kumar Sahoo |
NIMHANS |
Department of Neurology
Bangalore
KARNATAKA |
9740442515
lulupsahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levodopa and trihexyphenidyl |
Each patient will be given 2 drugs orally one after another (2 tab of L-Dopa 100 mg+ carbodopa 25mg and after 48 hour of wash period 2 tab of trihexyphenidyl 2mg) and response to drug will be recorded. patient will be given the 2 drugs once during the study to observe the response. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Parkinson’s disease patients (fulfilling MDS clinical diagnostic criteria for PD) (who are currently taking or had taken trihexyphenidyl in the past) |
|
| ExclusionCriteria |
| Details |
1. Patients with cognitive and behavioral disturbances.
2. Patients with history of urinary disturbances and benign hyperplasia of prostate.
3. Patients with angle closure glaucoma.
4. Patients with h/o cardiac illness
5. Patients with h/o postural hypotension.
6. Lack of consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in UPDRS motor scores after the treatment |
Baseline, after 1 hour of levodopa tablets, after 48 hours, after 30 minutes, after 60 minutes, after 90 minutes, after 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are very few studies assessing
the effectiveness of trihexyphenidyl in
improving motor symptoms in PD.Studies comparing effectiveness of trihexyphenidyl and levodopa in PD
patients are also very rare.We plan to evaluate 30 patients with Parkinson’s disease and objectively assess the response of their motor features to levodopa and trihexyphenidyl respectively. |