| CTRI Number |
CTRI/2009/091/000761 [Registered on: 07/10/2009] |
| Last Modified On: |
20/01/2012 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A clinicalm trial to study the effects of a herbal drug Dawa-e-Musakkin in patients with anxity and Tension |
|
Scientific Title of Study
|
A Clinical Study of Dawa-e- Musakkin in the treatment of Generalized Anxiety Disorder (GAD). |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yasmeen Shamsi |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Unit, Majeedia Hospital
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
01126059692, Ext. 5930, 5723 |
| Fax |
26059663 |
| Email |
yasmeen.ijum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yasmeen Shamsi |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Unit, Majeedia Hospital
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
01126059692, Ext. 5930, 5723 |
| Fax |
26059663 |
| Email |
yasmeen.ijum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yasmeen Shamsi |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Unit, Majeedia Hospital
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
01126059692, Ext. 5930, 5723 |
| Fax |
26059663 |
| Email |
yasmeen.ijum@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard National Foundation, New Delhi and Jamia Hamdard, New Delhi |
|
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Primary Sponsor
|
| Name |
Hamdard National Foundation, New Delhi |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Hamdard, New Delhi |
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Yasmeen Shamsi |
Clinical Research Unit, Majeedia Hospital |
Majeedia Hospital,Jamia Hamdard-110062
New Delhi
DELHI |
011-26059692, Ext. 5930
26059663
yasmeen.ijum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Jamia Hamdard |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Generalized Anxiety Disorder, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dawa-e-Musakkin |
2 gram OD for 3 months |
| Comparator Agent |
placebo |
2 gram OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
?Age and Sex- 18-60 years, either sex
?Patients diagnosed as cases of generalized anxiety disorder according to DSM-IV diagnostic Criteria
|
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| ExclusionCriteria |
| Details |
?Pregnancy or lactation
?Women patients above 45 years of age( Post menopausal women)
?Patients with past or current history of cigarette smoking, drug or alcohol abuse.
?Patients of hyperthyroidism or hypothyroidism.
?Patients with a history of hypoglycemic episodes.
?Any cardiovascular /or chest diseases
|
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in mean Hamilton Anxiety Rating score |
4,8,12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in performance |
3 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/03/2003 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/03/2003 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Tis study is a randomized , double blind parallel group trial comparing tthe efficacy of a herbal drug Dawa-e-Musakkin 2 gram daily with Placebo 2 gram daily in 50 patients of Generalized Anxiety Disorder for 3 months. |