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

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. - SERRATB TRIAL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097027

Enrollment

740

Registered

2025-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A188- Tuberculosis of other specified organs

Interventions

Intervention1: Serrtiopeptidase with standard anti tuberculosis treatment: 15 mg tablets twice a day for 60 days for two months along with standard anti tuberculosis treatment Control Intervention1: S

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Amitabh Das Shukla

Moti Lal Nehru Medical College Prayagraj (Allahabad)

adshukla1977@yahoo.com9335867395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026