| CTRI Number |
CTRI/2024/10/075849 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effect of ayurvedic tablet in tuberculosis along with anti kochs treatment |
|
Scientific Title of Study
|
Efficacy of jayanti ashwagandha vatti as adjuvent therapy with antikochs treatment in pulmonary tuberculosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr pritee omprakashji Varma |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital |
| Address |
Department of kayachikitsa, first floor
Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
9860959225 |
| Fax |
|
| Email |
priteevarma1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama jitendra shimpi |
| Designation |
Associate proffesor |
| Affiliation |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital |
| Address |
Department of kayachikitsa, first floor
Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
7387480800 |
| Fax |
|
| Email |
dranupamashimpi72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama jitendra shimpi |
| Designation |
Associate proffesor |
| Affiliation |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital |
| Address |
Department of kayachikitsa, first floor
Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
7387480800 |
| Fax |
|
| Email |
dranupamashimpi72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital
583/2 Rasta Peth Pune-411011
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital |
| Address |
583/2,Rasta Peth,Pune-411011.
Maharashtra
India |
| 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 pritee omprakashji varma |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital |
Dots opd, Ground floor
Department of Kayachikitsa
Pune
MAHARASHTRA |
960959225
priteevarma1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Tilak Ayurved Mahavidyalaya and seth Tarachand ramnath charitable ayurved hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A150||Tuberculosis of lung. Ayurveda Condition: RAJAYAKSHMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: jayanti ashwagandha vati, Reference: Rasaratnasamuchya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: 80 ml milk), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | DOT therapy | NTEP Treatment regimen for TB
DOSE AND FREQUENCY: 4FDC [Rifampicin 150mg,Isoniazid 75mg,Pyrizinamide 400mg,Ethambutol 275mg] for Intensive phase of 2 months and 3FDC[Isoniazid 75mg,Rifampicin 150mg,Ethambutol 275mg] for Continuation phase of 4 months
ROUTE: Oral
Duration:6 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sputum positive for pulmonary tuberculosis,
sputum negative, chest xray positive,
Drug sensitive TB patients |
|
| ExclusionCriteria |
| Details |
extra pulmonary tb,
MDR tb,
pregnant women and child patients,
psychologically disturbed patients,
Drug resistance tb patients,
patient having hepatotoxicicty, ototoxicity, other complications
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Temperature, Pain, Diarrhoea, Cough, weight gain, Haemoptysis, loss of appetite |
0th, 30th, 60th, 120th, 150th, 180th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sputum for AFB, CXR when required, USG when required |
0th, 30th, 60th, 120th, 150th, 180th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The largest number of cases occurs in the Southeast Asia region which accounts for about a third of the global prevalence and populated nations like China and India are on alarming bomb. Moreover, India is the highest TB burden country accounting for more than one fifth of the global incidence.To prevent acquired resistance and a successful treatment; it is recommended to receive a combination chemotherapy containing the main drugs Isoniazid -H (INH), Rifampicin-R (RMP) and Pyrazinamide-Z (PZA), ethambutol (EMB)and/or Streptomycin. These drugs are used in combination for initial 2 month followed by a continues use of INH + RMP for 4-6 month as a complete treatment regimen for active tuberculosis. To reduce the incidence of hepatotoxicity in TB patients, various measures have been taken with revised recommendations for drugs and patient selection criteria. But until today no drug has been developed in conventional health science for prevention of hepatotoxicity. The only measure available for managing ATT induced hepatotoxicity is withdrawal of the therapeutic drugs when observed an evidence of liver damage and reintroducing the same after normalization of liver enzymes. It has been observed that most of the patients suffering from Tuberculosis find difficulty to complete the recommended treatment regimen due to hepatotoxicity caused due to the ATT drugs. Thus, some adjuvant therapy is essential which could reduce the hepatotoxicity of the therapeutic drugs. Therefore, keeping these facts in mind this study has been planned to provide better, safer and faster relief to thepatients suffering from Tuberculosis and for this I have choose use of Rasayana therapy purpose a compound formulation of Jayanti vati along with Ashwagandha has been prepared. Both of these drugs have well established hepato protective, immuno-modulatory action and are frequently used by Acharyas for the treatment of tuberculosis due to their Rasayana properties. |