| CTRI Number |
CTRI/2021/05/033863 [Registered on: 28/05/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of
Ashwagandhadi Avaleha as an Adjuvant with Anti Tubercular Treatment. |
|
Scientific Title of Study
|
A Pre-clinical and Clinical Study to evaluate the efficacy of
Ashwagandhadi Avaleha as an Adjuvant in the management of
Tuberculosis with Anti Tubercular Treatment. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana Mishra |
| Designation |
Reader, Deptt. of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital , Paprola |
| Address |
RGGPG Ayurvedic College and Hospital , Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjana Mishra |
| Designation |
Reader, Deptt. of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital , Paprola |
| Address |
RGGPG Ayurvedic College and Hospital , Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Thakur |
| Designation |
PG Scholar Dept. of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital , Paprola |
| Address |
RGGPG Ayurvedic College and Hospital , Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9814016525 |
| Fax |
|
| Email |
pratibha090.thakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy, Paprola Dist Kangra H.P
Self
Charak Pharmacy RGGPG Ayurvedic College
and Hospital , Paprola |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG Ayurvedic College and Hospital , Paprola |
| 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 |
| Dr Anjana Mishra |
RGGPG AYURVEDIC COLLEGE AND HOSPITAL |
Room No. 207 Rajiv Gandhi Govt PG Ayurvedic college and Hospital Paprola
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(Human) R.G.G.P.G Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: RAJAYAKSHMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi Avaleha |
Ashwagandhadi Avaleha
10gm BD
along with Anti Tubercular Treatment (HRZE)
for 8 weeks(intensive phase of ATT regimen) |
| Comparator Agent |
HRZE(Isoniazid, Rifampicin, Pyrazinamide, Ethambutol) |
HRZE for 8weeks(intensive phase of ATT regimen) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Freshly diagnosed cases of tuberculosis(Pulmonary Tuberculosis and Tubercular pleural
effusion)
2. Patients of either sex between the age of 15-70 years.
3. Patients willing and able to participate for 8 weeks duration |
|
| ExclusionCriteria |
| Details |
1. MDR and XDR cases of tuberculosis.
2. Patients having diabetes mellitus.
3. Patient with uncontrolled hypertension.
4. Suffering from any other chronic infections including HIV.
5. Patients Below the age of 15yrs and above the age of 70yrs.
6. Patients not willing for trial.
7. Individuals who have completed participation in any other clinical trial during the past three
months.
8. Any other condition which the Principal investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Ashwagandhadi Avaleha to reduce/prevent toxicity when administered as add on therapy
along with Anti tubercular drugs in the management of Tuberculosis |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the Ashwagandhadi Avaleha in improving general well being. |
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my trial after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of R.G.G.P.G. Ayurvedic College & Hospital, Paprola. Two groups of 60 patients will be assessed to evaluate the efficacy of Ashwagandhadi Avaleha as an Adjuvant in management of Tuberculosis along with Anti Tubercular Treatment.
|