| CTRI Number |
CTRI/2025/11/097027 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of adding serratiopeptidase in improving the clinical outcome of anti tuberculosis treatment among patients of various types of extra pulmonary tuberculosis |
|
Scientific Title of Study
|
A randomized controlled study to assess role of serratiopeptidase as companion drug to standard anti tuberculosis drug regimen in achieving good clinical outcome among patients of Extra Pulmonary Tuberculosis. |
| Trial Acronym |
SERRATB TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/MLNMC/2025/No. OP- 02 dated 28.08.2025 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amitabh Das Shukla |
| Designation |
Professor |
| Affiliation |
Moti Lal Nehru Medical College Prayagraj (Allahabad) |
| Address |
Pulmonary Medicine
Swaroop Rani Nehru Hospital
Moti Lal Nehru Medical College
Prayagraj (Allahabad)
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9335867395 |
| Fax |
|
| Email |
adshukla1977@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitabh Das Shukla |
| Designation |
Professor |
| Affiliation |
Moti Lal Nehru Medical College Prayagraj (Allahabad) |
| Address |
Pulmonary Medicine
Swaroop Rani Nehru Hospital
Moti Lal Nehru Medical College
Prayagraj (Allahabad)
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9335867395 |
| Fax |
|
| Email |
adshukla1977@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitabh Das Shukla |
| Designation |
Professor |
| Affiliation |
Moti Lal Nehru Medical College Prayagraj (Allahabad) |
| Address |
Pulmonary Medicine
Swaroop Rani Nehru Hospital
Moti Lal Nehru Medical College
Prayagraj (Allahabad)
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9335867395 |
| Fax |
|
| Email |
adshukla1977@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MRU CCT Grant sponsored by Department of Health Research MoHFW Government of India atMLN Medical College Prayagraj-211001 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
MRU sponsored by Department of Health Research MoHFW |
| Address |
Moti Lal Nehru Medical College Prayagraj-211001 Uttar Pradesh India |
| Type of Sponsor |
Government medical college |
|
|
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 Amitabh Das Shukla |
Moti Lal Nehru Medical College Prayagraj |
Room Number 1, IPD building; Room Number 3/2, OPD building, Department of Pulmonary Medicine
Swaroop Rani Nehru Hospital
Moti Lal Nehru Medical College Prayagraj 211001
Allahabad
UTTAR PRADESH |
9335867395
adshukla1977@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MLN Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A188||Tuberculosis of other specified organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serrtiopeptidase with standard anti tuberculosis treatment |
15 mg tablets twice a day for 60 days for two months along with standard anti tuberculosis treatment |
| Comparator Agent |
Standard anti tuberculosis treatment |
Standard of care anti tuberculosis treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with following-
1. Newly diagnosed cases of extra pulmonary tuberculosis as diagnosed by consultant of respective department. Type of extra pulmonary tuberculosis, planned to be recruited and evaluated in present study include:
a. Pleural tuberculosis
b. Neurological tuberculosis
c. Lymph Node tuberculosis
d. Pericardial tuberculosis
e. Abdominal tuberculosis
f. Bone tuberculosis
g. Gynaecological tuberculosis
h. Urinary tuberculosis
2. Age more than 18 years, either sex
3. Willing to give a written informed consent for participation in study |
|
| ExclusionCriteria |
| Details |
i) Pulmonary tuberculosis
ii) HIV seropositivity, Diabetes mellitus, liver disease, psychiatric illness, hypothyroidism, pregnancy, breastfeeding women
If patient is already having complications of extra pulmonary tuberculosis
iv) Female taking oral contraceptive pills.
v) Taking systemic steroid.
vi) Patients on anticoagulant therapy
vii) History of anti-tubercular treatment in past
viii) History of allergic reaction to serratiopeptidase.
ix) Patient not giving consent for participation in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proposed study is expected to show decreased complications and better clinical outcome in patients of extra pulmonary tuberculosis who has taken the drug serratiopeptidase as a companion drug to standard anti tuberculosis drug regimen. |
Baseline, 1 month, 2 month, 3 month, 4 month, 5 month and 6 month for all patients.
Additionally 7 month, 8 month and 9 month, only among patients of Neurological tuberculosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="740"
Sample Size from India="740"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Tuberculosis (TB) continues to be a major public health challenge globally, especially in low and middle income countries like India. While pulmonary TB is more commonly recognized, extrapulmonary tuberculosis (EPTB) comprises a significant portion of the disease burden, accounting for approximately 15 to 20 percent of cases in immunocompetent individuals and over 50 percent in immunocompromised populations such as those living with HIV or AIDS.EPTB may affect virtually any organ including lymph nodes, pleural skeletal systems, genitourinary tract, abdomen, central nervous system
(CNS), pericardium, and reproductive organs. The complications associated with
EPTB vary depending on the site of involvement and may include abscess
formation, pleural thickening, vertebral deformities, infertility, neurological
deficits, and even life-threatening conditions like cardiac tamponade and
hydrocephalus. These complications often arise due to delayed diagnosis,
prolonged inflammation, and inadequate tissue healing. This randomized
controlled study is designed to evaluate the efficacy of serratiopeptidase
drug, a proteolytic enzyme with anti-inflammatory, fibrinolytic, and analgesic
properties, as an adjunct to standard anti-tubercular therapy (ATT) in
preventing complications and achieving better clinical outcomes in EPTB.
Serratiopeptidase has been used in various inflammatory and post-operative
conditions, and preliminary retrospective data suggest its potential in
enhancing tissue healing and reducing complications in TB-related
hydro-pneumothorax. Given this background, this study aims to systematically
evaluate its benefits in multiple forms of EPTB. The study will be conducted in
2025 at the Department of Pulmonary Medicine, SRN Hospital, MLN Medical
College, Prayagraj. Eligible participants will include adult patients (greater
than 18 years) newly diagnosed with EPTB, confirmed by experts in the respective
organ systems based on relevant clinical and diagnostic criteria. Patients will
be randomized into two groups: the intervention group will receive
serratiopeptidase 15 mg twice daily for 2 months (during intensive phase of
ATT), alongside standard full course ATT regimen under National TB Elimination
Program (NTEP), while the control group will receive standard full course ATT
only, under NTEP. Exclusion criteria include pulmonary TB, co-morbid conditions
such as HIV, diabetes, liver disease, pregnancy, steroid or anticoagulant
therapy, prior TB treatment, or known allergy to serratiopeptidase. Participants
will undergo baseline investigations, including CBC, LFT, KFT, PT or INR, HIV
status, HbA1C, and other organ-specific diagnostics. Monthly follow-up visits
will monitor clinical improvement and identify any emerging complications or
adverse effects. Relevant lab investigations will be repeated during each
follow-up.The primary objective is to determine whether the addition of
serratiopeptidase for 2 months to standard ATT regimen, can achieve good
clinical outcome and reduce the incidence and severity of complications
associated with EPTB.The data collected will be analyzed using appropriate
statistical tools to assess efficacy and safety outcomes. This study is
expected to contribute significantly to the evidence base supporting adjunctive
therapies in TB management, particularly in resource-constrained settings,
where reducing surgical interventions and improving recovery can have
substantial public health benefits. All patient data will be handled with
strict confidentiality, and institutional ethics approval will be obtained
before commencing the study.
|