| CTRI Number |
CTRI/2008/091/000089 [Registered on: 19/06/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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“To study the Immunomodulatory effects of Withania somnifera (ASHWAGANDHA) in patients of pulmonary tuberculosis†|
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Scientific Title of Study
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A proof of concept prospective, randomized parallel open clinical study to evaluate the effect of PHP-TB in patients of Pulmonary Tuberculosis. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| PHP/GMC-IIIM/2007 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. Vandana Razdan |
| Designation |
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| Affiliation |
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| Address |
Post Graduate Department of Pharmacology and Therapeutics
Govt. Medical College
Jammu
JAMMU & KASHMIR
180 001
India |
| Phone |
09419185207 |
| Fax |
0191-2569333 |
| Email |
vandanarazdan@rediffmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr.Vipender S. Chopra |
| Designation |
|
| Affiliation |
Professor& Head, Post graduate department of Pharmacology and Therapeutics |
| Address |
Professor& Head, Post graduate department of Pharmacology and Therapeutics
Govt. Medical College
Jammu
JAMMU & KASHMIR
180 001
India |
| Phone |
09419213602 |
| Fax |
0191-2543689 |
| Email |
vipen1956@hotmail.com, vipen.chopra@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Inshad Ali Khan |
| Designation |
|
| Affiliation |
|
| Address |
Scientist, Indian Institute of Integrative Medicine
Canal Road
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
09419134373 |
| Fax |
0191-2569333 |
| Email |
inshad@yahoo.com |
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Source of Monetary or Material Support
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| Government Medical College, Jammu and Council of Scientific & Industrial Research |
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Primary Sponsor
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| Name |
Government Medical College, Jammu |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| Indian Institute of Integrative Medicine, Jammu |
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Vijay Khajuria |
CD Hospital, Government Medical College, Jammu |
Assistant Professor, Post graduate department of Pharmacology and Therapeutics,Govt. Medical College-180001
Jammu
JAMMU & KASHMIR |
0191-2451935
0191-2543689
vijaykhaj@yahoo.co.in |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Medical College, Jammu |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Pulmonary Tuberculosis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Capsule PHP-TB containing hydro-alcoholic extracts of Withania somnifera 300mg |
Will receive a combipack containing Tab. Isoniazid(H) 600mg +Cap. Rifampicin (R) 450mg + Tab. Pyrazinamide (Z ) 1500mg + Tab. Ethambutol (E) 1200mg thrice a week + Cap.Withania somnifera 300mg once a day for Initial 2 months followed by Tab. Isoniazid (H) 600mg +Cap. Rifampicin (R) 450mg thrice a week + Cap. Withania somnifera 300mg once a day for next 4 months. |
| Comparator Agent |
Capsule Placebo |
Will receive a combipack containing Tab. Isoniazid (H) 600mg +Cap. Rifampicin (R) 450mg +
Tab. Pyrazinamide (Z) 1500mg +Tab. Ethambutol (E) 1200mg thrice a week + Cap.Placebo
once a day for Initial 2 months followed by Tab. Isoniazid (H) 600mg + Cap.Rifampicin(R)
450mg thrice a week +Cap. Placebo once a day for next 4 months.
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Patients between 25-50 yrs. of age of either sex,
2. Newly diagnosed untreated patients of pulmonary tuberculosis.
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| ExclusionCriteria |
| Details |
1. Extra pulmonary cases of tuberculosis.
2. History of chronic alcohol intake or smoking.
3. HIV Positivity, diabetes mellitus, autoimmune disease, Hepatitis B.
4. Pregnancy and lactation.
5. Has participated in any investigational study 4 weeks prior to the enrollment in this study.
6. Known history of hypersensitivity reactions.
7. Confirmed or suspected immunosuppressive or immune deficient condition.
8. Family h/o congenital or hereditary immunodeficiency
9. Chronic administration of immunosuppressants or other immune modifying agents 6 months prior to the study.
10. Administration of immunoglobulins 3 months preceding the enrollment in the study.
11. Patients with impaired hepatic functions.
12. Patients with impaired renal functions.
13. Seizure disorder
14. Patients with known symptoms of cardiac disease like Coronary artery disease, arrhythmias.
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| The patients will be evaluated for various parameters like weight gain, improved QOL , sputum for AFB , X-ray chest ,Elisa for TNF - α and IL-1β and flow cytometry for various immune parameters like IFN-Ύ, IL-2, CD3+, CD4+, CD8+. |
8 weeks onwards |
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Secondary Outcome
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| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
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Target Sample Size
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Total Sample Size="120"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The present prospective open randomized parallel study will be conducted in the post graduate department of pharmacology and therapeutics in collaboration with the department of chest diseases, Govt. Medical College Jammu and Indian Institute of Integrative Medicine (CSIR), Jammu
The study will be done to evaluate the effect of PHP-TB i.e. formulation containing hydro-alcoholic extracts of the roots of Withania somnifera (300mg) in comparison with Placebo (300mg) in patients of Pulmonary Tuberculosis. Newly diagnosed 60 patients of pulmonary tuberculosis will be given anti-tubercular treatment for 6 months – Group I. Likewise, newly diagnosed 60 patients of pulmonary tuberculosis will be given anti-tubercular treatment along with Withania somnifera (PHP-TB) cap.for 6 months –Group II. 60 normal healthy individuals from similar population will be taken as a control group – Group III. The primary outcome measures will be 10% improvement in biochemical and immunological parameters over and above that obtained in the group receiving placebo and less than 10% difference in adverse events between placebo and active treatment groups.
Both the groups will be evaluated for parameters like weight, LFT, sputum, X-ray chest and Elisa and flow cytometry for immune parameters.
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