| Reference No. | Study title | Principal Investigator | Sponsor | Investigational Product | Status/Outcome |
| CLITRI/2020/0008 | Effectiveness of Oral Serratiopeptidase in Reduction of lower limb cellulitis: A randomized controlled study | Dr. N.L Mohitti | Investigator-driven | Serratiopeptidase | Awaiting responses of the applicant to review comments |
| CLITRI/2020/0032 | Hydroxychloroquine for Post-Exposure Prophylaxis of COVID-19 among naval personnel: a placebo-controlled, randomized, clinical trial | Prof. Madunil Niriella | Investigator-driven | Hydroxychloroquine |
Approved on 05.05.2020 (processed under fast-track procedure) Abandoned due to noncompliance by study participants following adverse media reports on HCQ |
| CLITRI/2020/0033 | "Zafirlukast" for the treatment of Coronavirus disease (COVID-19): A randomized double-blind placebo-controlled clinical trial-under review | Prof. P. Galappatthy | Local research grant | Zafirlukast | Awaiting responses of the applicant to review comments (received under fast-track procedure) |
| CLITRI/2020/0039 | A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication. | Prof. Shehan Williams | Newron Pharmaceuticals SpA, Italy | Evenamide | Awaiting responses of the applicant to review comments |
| CLITRI/2020/0040 | An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment-resistant schzophrenia (TRS) not responding adequately to their current antipsychotic medication. | Prof. Shehan Williams | Newron Pharmaceuticals SpA, Italy | Evenamide | Awaiting responses of the applicant to review comments |
| Reference No. | Study title | Principal Investigator | Sponsor | Investigational product | Status/Outcome |
| CTM/13/18 | Efficacy & safety of oral hydroxyurea in transfusion dependent beta thalassemia: randomized double blind placebo controlled | Dr. Sachith Mettananda (University of Kelaniya) | Local research grant (NSF) | Hydroxyurea | Approved on 08.03.2019 |
| CTM/14/18 | Prophylactic dexamethasone for the prevention early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer | Dr. Umesh Jayarajah (University of Colombo) | Investigator-driven | Dexamethasone | Not approved (New application submitted with prednisolone as IMP , following review comments) |
| CTM/15/18 | Efficacy & safety of chelation therapy with calcium disodium EDTA in the progression of CKDu in Sri Lanka - A double blinded placebo controlled randomized controlled clinical trial | Dr. Eranga Wijewickrama (University of Colombo) | Local research grant (University of Colombo) | Edetate calcium disodium | Not approved(No response to review comments) |
| CTM/16/18 | Oxidative stress in CKDu and the efficacy and safety of vit C and vit E in slowing progression of early stages of CKD u in Sri Lanka – A randomized double blind placebo controlled trial | Prof. Saroj Jayasinghe (University of Colombo) | Local research grant (University of Colombo) | Vitamin C, Vitamin E | Not approved(No response to review comments) |
| CTM/17/19 | A phase III, multicenter, multi-country, open label, randomized, active controlled clinical trial to evaluate the efficacy and safety of Desisustat vs Darbepoetinfor the treatment of Anaemia in patients with CKD who are not on dialysis | Dr. A. L. M. Nazar (NHSL, Colombo) | Cadila Healthcare, India | Desidustat | Approved on 21.08.2019 |
| CTM/18/19 | Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer | Dr. Umesh Jayarajah (University of Colombo) | Investigator-driven | Prednisolone | Approved on 04.12.2019 |
| CTM/19/19 | A randomized controlled trial of the efficacy of activated charcoal in paracetamol overdose | Dr. N.K. Anjana Silva (Rajarata University) | SACTREC | Activated Charcoal | Regulatory approval not required (To proceed with ethics approval) |
| CTM/20/19 | rVA576 (Covesin) Long Term Safety and Efficacy Surveillance Study | Dr. Senani Williams | Akari Therapeutics, United Kingdom | rVA576 (a recombinant small protein) | Approved on 18.11.2019 |
| CTM/21/19 | A phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of Ataluren in patients with nonsense mutation Duchenne muscular dystrophy and open-label extension | Prof. Harendra De Silva | PTC Therapeutic Inc, USA | Ataluren | Under review |
Applicant
| Reference No. | Title | Applicant | Date of approval |
| CTM/002/2017 | A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter, Multinational Study to evaluate the efficacy and safety of TRC 150094 as an addon to standard of care in improving cardiovascular risk in subjects with diabetes, dyslipidaemia and hypertension. | Dr. Noel Somasundaram (Coordinating PI:) | 10.01.2018 |
| CTD/001/2017 | Effectiveness of Paranasal Sinus Air Suction in the Treatment of Acute Migraine Headache - A Randomized, Double-Blind, Placebo-Controlled Study |
Dr. S.M Rathnasiri Bandara (Principal Investigator) |
16.01.2018 |
| CTM/007/2017 | Efficacy and Safety of Once Weekly Thyroxine versus Daily Thyroxine as maintenance Therapy of Hypothyroidism: A Randomized, Controlled Exploratory Clinical Trial. | Dr. Uditha Bulugahapitiya (Principal Investigator) | 18.04.2018 |
| CTM/003/2017 | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/005/2017 | Combined Phase 3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/008/2017 | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluating the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/010/2018 | Effects of the Lysulin TM supplementation on pre-diabetes: a randomized double-blind, placebo-controlled clinical trial. |
Dr. M.A Ranil Jayawardena (Principal Investigator) |
05.06.2018 |
| CTM/004/2017 | A Long term extension study to evaluate the safety of Filgotinib in subjects with Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 06.06.2018 |
| CTM/006/2017 | A Long term extension study to evaluate the safety of Filgotinib in subjects with Crohn’s Disease. | Prof. Arjuna de Silva (Coordinating PI:) | 06.06.2018 |
| CTM/011/2018 | CAPSTONE: Phase III Confirmatory Assessment Protocol: rVA576 Safety and Efficacy in Three-Part, Two-Arm, Randomized Open Label Evaluation in Patients with Paroxymal Nocturnal Haemoglobinuria (PNH). | Dr. Senani Williams (Principal Investigator) | 03.08.2018 |
| CTM/009/2018 | The efficacy and safety of N-acetylcysteine in patients with acute kidney injury complicating leptospirosis – A randomized controlled clinical trial | Prof. Senaka Rajapakse (Principal Investigator) | 31.12.2018 |