Last Updated on June 29, 2022
Division of Pharmacy Services, DRAP, under Rule 20 of the Bio-Study Rules 2017 maintains a clinical trial registry for approved clinical trials involving human subjects being conducted in Pakistan.
Drug Regulatory Authority of Pakistan has recently adapted U.S. National Trial Registry as an international registry for all clinical trial approved by the Clinical Studies Committee, DRAP.
- Principal Investigators / Responsible parties (Sponsors) nominate a focal person from their organizations, to open & maintain PRS (Protocol Registration & Results System) account.
- All Principal Investigators / Responsible parties (Sponsors) will enlist their approved Clinical Trials on U.S. National Trial Registry and after getting “NCT” identifier number will inform to Division of Pharmacy Services-DRAP.
- NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered on the U.S. National Trial registry.
Clinical Trials Subject Registry
A verifiable record of the clinical trial participants or subjects be maintained to stop duplicate enrolment and also to improve both patient safety and preserve data integrity of clinical trials. The subject identification shall be a closed information from the investigator, directly submitted to the DRAP.
Following is the list of approved Clinical Trials:-
| S.No | CT Reg. | Title of Clinical Trial / Clinical Study | Phase | Clinical Trial Site (CTS) | Date of approval | Initial duration | |
|---|---|---|---|---|---|---|---|
| 1 | CT-0001 | Tranexamic Acid (TXA) For reducing postpartum bleeding in women with Anemia: An International, Randomized, Double Blind, Placebo Controlled Trial Women-II Trial | Phase-III | CTS-0001 | Gynae Unit-I & II, Holy Family Hospital, Said Pur Road. Rawalpindi. | 18th July 2019. | 38 Months |
| CTS-0005 | Department of Gynae & Obstetrics, Benazir Bhutto Hospital, Rawalpindi. | ||||||
| CTS-0006 | Gynae Section, Services Institute of Medical Sciences, Lahore. | ||||||
| CTS-0007 | Department of Gynae & Obstetrics, Nishtar Medical University & Hospital, Multan. | ||||||
| CTS-0008 | Department of Gynae & Obstetrics, Sir Ganga Ram Hospital, Fatima Jinnah Medical University, Lahore. | ||||||
| CTS-0009 | Gynae Unit-II,Allama Iqbal Medical College, Jinnah Hospital, Lahore. | ||||||
| CTS-0010 | Department of Gynae & Obstetrics, Pak-Emirates Military Hospital, Rawalpindi. | ||||||
| CTS-0011 | Department of Gynae & Obs, Shaikh Zaid Women Hospital, Chandka Medical College, Shaheed Benazir Bhutto Medical University, Larkana. | ||||||
| CTS-0012 | Department of Gynae & Obstetrics, Federal Govt Poly Clinic Hospital, Islamabad. | ||||||
| CTS-0013 | Gynae Unit-I & II, Bahawal Victoria Hospital, Bahawalpur. | ||||||
| CTS-0014 | MCH Unit-II, Pakistan Institute of Medical Sciences (PIMS), MCH Centre, Islamabad. | ||||||
| CTS-0015 | Dow University of Health Sciences / Dr Ruth Km Pfau Civil Hospital, Karachi. | ||||||
| CTS-0016 | Gynae Ward-09, Jinnah Postgraduate Medical Centre, Karachi. | ||||||
| CTS-0017 | Gynae Unit-II, Aziz Bhatti Shaheed Teaching Hospital, Bhimbar Road Gujrat, Nawaz Sharif Medical College, University of Gujrat. | ||||||
| CTS-0023 | Sandeman Provincial Hospital, Quetta. | ||||||
| CTS-0024 | Department of Gynae & Obstetrics Bolan Medical Complex, Quetta. | ||||||
| CTS-0025 | Department of Gynae & Obstetrics Ayub Medical Teaching Institution, Abbotabad. | ||||||
| CTS-0028 | Gynae Section Koohi Goth Women Hospital, Karachi | ||||||
| 2 | CT-0002 | Lonafarnib / 100mg Ritonavir Bid With & Without 180mcg PEG IFN-Alfa-2a for 48 Weeks, Compared with PEG IFN-Alfa-2a Mono-therapy and Placebo Treatment in Patient Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos (T) Ide Therapy (D-LIVR). (Phase-III) | Phase-III | CTS-0003 | The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi. | 13th November 2019. | 24 Months |
| 3 | CT-0003 | An International, Multi-Centre Controlled Randomized Clinical Trial to Evaluate Rifampicin 1200 Mg and 1800 Mg Daily in the Reduction of Treatment Duration for Pulmonary Tuberculosis from 06 Months to 04 Months. (Rifa-Shot) (Phase-III) | Phase-III | CTS-0003 | The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi. | 12th February 2020. | 24 Months |
| CTS-0004 | Shaukat Khanum Memorial Cancer Hospital, Lahore. | ||||||
| 4 | CT-0004 | Lactoferrin evaluation in anemia in pregnancy (Leap-1) a multicounty randomized control clinical trial. | Phase-III | CTS-0003 | The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi. | 15th April 2020. | 24 Months |
| 5 | CT-0005 | endTB (Evaluating Newly Approved Drugs for Multidrug Resistant TB) Phase-III Clinical Trial, At the Indus Hospital Karachi. | Phase-III | CTS-0002 | Ghauri Clinic of the Indus Hospital, Karachi. | 10th February 2020. | 60 Months |
| CTS-0036 | Institute of Chest Diseases Kotri, Jamshoro, Sindh, Pakistan. (CTS-0036), approval date 24th August 2020. | ||||||
| 6 | CT-0006 | endTB-Q Evaluating Newly Approved Drugs in Combination Regimens for Multi Drug- Resistant TB with Fluoroquinolone Resistance (Q) (EndTB-Q) Phase-III Clinical Trial, at the Indus Hospital Karachi. | Phase-III | CTS-0002 | Ghauri Clinic of the Indus Hospital, Karachi. | 10th February 2020. | 60 Months |
| CTS-0036 | Institute of Chest Diseases Kotri, Jamshoro, Sindh, Pakistan. (CTS-0036), approval date 24th August 2020. | ||||||
| 7 | CT-0007 | Perioperative Ischemic Evaluation-3 (Poise-3). | Phase-III | CTS-0026 | Shifa Clinical Research Center, Shifa Intonational Hospital Ltd, Islamabad | 12th February 2020. | 48 Months |
| 8 | CT-0008 | A Multi-Country, Multi-Center, Two Arm, Parallel, Double Blind, Placebo Controlled, Randomized Trial of Antenatal Corticosteroids (Dexamethasone) For Women at Risk of Imminent Birth in The Early Pre-Term Period (Action I Trial) And Late Pre-Term Period (Action II Trial) In Health Facilities in Low-Resource Settings to Improve Newborn Outcomes. | Phase-IV | CTS-0030 | Liaquat University Hospital, Jamshoro. | 3rd February 2020. | 24 Months |
| CTS-0031 | Sheikh Zaid Hospital, Raheem Yar Khan. | ||||||
| 9 | CT-0009 | Open-Label Study of Oral Ibrexafungerp (SCY-078) in Patients with Auris-SCY-078-Aga Khan Hospital-Phase-III CT. | Phase-III | CTS-0003 | The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi. | 27th August 2020. | 132 Days |
| 10 | CT-0010 | Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide 60 mg Modified Release Tablet in patients with Type-II diabetes, fasting during Ramadan. | Phase-IV | CTS-0018 | Akram Medical Complex, Lahore. | 12th February 2020. | 06 Months |
| CTS-0019 | Diabetes Institute of Pakistan, Jail Road, Lahore. | ||||||
| CTS-0020 | National Hospital and Medical Center, Lahore. | ||||||
| CTS-0021 | Hayatabad Medical Complex (Medical Teaching Institute), Peshawar. | ||||||
| CTS-0027 | Baqai Institute of Diabetes and Endocrinology, Karachi. | ||||||
| 11 | CT-0011 | Prevention of maternal and neonatal death/infections with a single oral dose of azithromycin in women in labor (in low & middle-income countries). A Randomized, Controlled Trial (A-PLUS) | Phase-III | CTS-0029 | Gynae Department, Jinnah Postgraduate Medical Center (JPMC) Karachi. | 12th February 2020. | 36 Months |
| 12 | CT-0012 | Heparin Anticoagulation to improve Outcomes in Septic Shock (HALO-Trial) | Phase-II | CTS-0032 | The Indus Hospital, Karachi. | 20th February 2020. | 36 Months |
| CTS-0033 | Mayo Hospital, Lahore. | ||||||
| CTS-0034 | Dow University of Health Sciences Karachi, (For two sub sites) | ||||||
| · Shaheed Mohtarma Benazir Bhutto Trauma Center, Karachi. | |||||||
| · Medical Unit of Dr. Ruth K.M. Pfau, Civil Hospital, Karachi | |||||||
| 13 | CT-0013 | Colchicine for the Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery" (COP-AF) Protocol No. 2017-001-COPAF. | Phase-III | CTS-0026 | Shifa Clinical Research Center, Shifa International Hospital Islamabad. | 03rd September 2020. | 52 Months |
| 14 | CT-0014 | Open labelled randomized Phase-I / II Clinical Trial to assess the Safety & efficacy of Iodine Complex (Renessans) | Phase-I | CTS-0037 | M/s Lahore General Hospital, Post Graduate Medical Institute, Lahore. | 20th October 2020. | 03 Months |
| 15 | CT-0015 | Application for Approval and Registration of Clinical Trial Titled Phase-III, Double Blind, Placebo-Controlled, Randomized Clinical Trial of Recombinent Novel Corona Virus Vaccine (Adenovirus Type 5 Vector) | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. | 24th August 2020. | 04 Months |
| CTS-0002 | The Indus Hospital, Karachi. | ||||||
| CTS-0004 | Shaukat Khanum Memorial Cancer & Research Hospital, Lahore. | ||||||
| CTS-0026 | Shifa International Hospital, Islamabad. | ||||||
| 16 | CT-0016 | Application for Approval of Clinical Trial Titled Randomized, Double Blinded, Parallel, Placebo Controlled, Phase-I Clinical Trial to Evaluate the Safety & Immunogenicity of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 18 & Above | Phase-I | CTS-0002 | The Indus Hospital, Karachi. | 24th August 2020. | 56 Days |
| 17 | CT-0017 | Effect of Micronutrients and life Skills Education on the Health and Nutrition of Adolescent and young women in Pakistan. | Phase-III | CTS-0003 | The Aga Khan Universitys Matiari Research & Training Center, Matiari, Sindh, | 24th August 2020. | 48 Months |
| 18 | CT-0018 | Capsule Endomicroscopy for visualization of the Small Intestine m EED (Environmental Enteric ln Dysfunction) population Pakistan. | CTS-0003 | The Aga Khan Universitys Matiari Research & Training Center, Matiari, Sindh, | 28th August 2020. | 29 Months | |
| 19 | CT-0019 | A Multicenter, Randomized, Double Blind, placebo Controlled, Phase-II Clinical Trial on The Effectiveness & Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID-19 patients. | Phase-II | CTS-0002 | The Indus Hospital, Karachi. | 25th August 2020. | 12 Months |
| 20 | CT-0020 | Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-l9) in the Healthcare Setting; a Randomized, Placebo controlled Prophylaxis Study (COPCOV) | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. | 28th August 2020. | 05 Month |
| 21 | CT-0021 | Clinical evaluation of the Panbio COVID-19 Ag Antigen Test in Symptomatic Subjects (CATSS) | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. | 27th August 2020. | 04 Months |
| 22 | CT-0022 | Immunoglobulin Therapy for Passive Immunization of Critically Ill Covid-19 Patients. | Phase-I | CTS-0040 | M/s Dow University Hospital, Dow University of Health Sciences-Ojha Campus,Karachi | 22nd January 2021. | 12 Months |
| CTS-0041 | M/s Sindh Infectious Diseases Hospital & Research center, Karachi | ||||||
| 23 | CT-0023 | A Phase III Randomized, Double Blind, Placebo Controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, A Recombinant Novel Corona Vaccine (CHO Cell) For Prevention of COVID-19. | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. | 19th March 2021 | 03 Months |
| CTS-0002 | The Indus Hospital, Karachi | ||||||
| CTS-0020 | National Hospital & Medical Center, Lahore. | ||||||
| CTS-0004 | Shaukat Khanum Memorial Cancer Hospital & Research Center, Lahore | ||||||
| CTS-0038 | University of Health Sciences, Lahore. | ||||||
| CTS-0051 | Chughtai Laboratory, Lahore. | ||||||
| CTS-0048 | Abdul Waheed Trust, Avicenna Dental College, Lahore. Avecinna | ||||||
| CTS-0049 | Central Park Teaching Hospital, Lahore | ||||||
| CTS-0050 | M/s Aziz Fatima Hospital, Faisalabad. | ||||||
| CTS-0044 | M/s Al-Shifa Trust Research Center | ||||||
| CTS-0052 | Clinical Assessment Unit, Examination Unit of M/s Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad | ||||||
| 24 | CT-0024 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase-II Clinical Trial to Evaluate the Efficacy & Safety of CBP-307 in Subjects with Moderate to Severe Ulcerative Colitis (UC). | Phase-II | CTS-0003 | Aga Khan University Hospital, Karachi. | 17th March 2021. | 13 Months |
| 25 | CT-0026 | A Multicenter, Seamless, Blind clinical Trial to Evaluate the Safety & Efficacy of Meplazumab (Injection) In Addition to Standard Care for The Treatment of COVID-19 In Hospitalized Adults | Phase-II | CTS-0003 | Aga Khan University Hospital, Karachi. | 31st March 2021. | 84±7 Days |
| 25 | CT-0027 | Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients with Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI). | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. | 31st March 2021. | 222 Days |
| 27 | CT-0028 | Randomized, Open Label, Multicenter, Non-Inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica. | Phase-IV | CTS-0055 | M/s Mohtarma Shaheed Bhutto General Hospital, Mariabad, Quetta. | 14th June 2021 | 24 Months (Two years or until 832 subjects are recruited for the trial). |
| CTS-0056 | M/s Médecins Sans Frontières, Kuchlak Primary Health Center, Quetta. | ||||||
| 28 | CT-0029 | A Randomized, Double-Blind, Positive Controlled Study to Evaluate Efficacy & Safety of Fuke Qianjin Capsule in Patients with Pelvic Inflammatory Diseases. | Phase-II | CTS-0046 | M/s Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, Sindh. | 17th September 2021 | 12 Months |
| 29 | CT-0030 | Azithromycin & Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial). | - | CTS-0061 | Aga Khan University Hospital for Women, Karim Abad, Karachi. | - | - |
| CTS-0062 | Aga Khan University Hospital, Garden East, Karachi. (CTS-0062) | ||||||
| CTS-0063 | National Institute of Child Health (NICH), Karachi. (CTS-0063) | ||||||
| 30 | CT-0031 | Anti-Coronavirus Therapies to Prevent Progression of COVID-19 | Phase-III | CTS-0003 | Aga Khan University Hospital, Karachi. (CTS-0003) | 16th July 2021 | 12 Months |
| CTS-0058 | Tabba Heart Institute, Karachi. (CTS-0058) | ||||||
| CTS-0059 | Jinnah Postgraduate Medical Center, Karachi. (CTS-0059) | ||||||
| 31 | CT-0032 | A multicenter, randomized, double-blind, placebo-controlled study to assess safety and efficacy of SIR1-365 in patients with serious Covid-19. | Phase-IB | CTS-0003 | Aga Khan University Hospital, Karachi. | 06th August 2021 | 06 Months |
| CTS-0068 | Dow University of Health Sciences, Ojha Campus, Karachi. | ||||||
| CTS-0069 | Sindh Infectious Diseases Institute, Karachi. | ||||||
| 32 | CT-0033 | A randomized, double-blind controlled clinical trial DWJ1248 in prevention of COVID-19 infection after the exposure of SAR COV-2. | Phase-III | CTS-0018 | Akram Medical Complex, Lahore, 2-B,Main Gulberg, Jail Road Lahore. | 27th August 2021 | 12 Months |
| CTS-0048 | Avicenna Hospital, Lahore, Avicenna Dental College, Abdul Waheed Trust, Phase IX, DHA Bedian Road, Lahore. | ||||||
| CTS-0020 | National Hospital & Medical Center, Lahore. 132/2 St.123, Sector L, DHA Phase-I, Lahore. | ||||||
| 33 | CT-0034 | Comparison of 1-month versus 12-month Dual Antiplatelet Therapy after implantation of Drug-Eluting Stents Guided by either Intravascular Ultrasound or Angiography in Patients with Acute Coronary Syndrome: The Prospective, Multicenter, Randomized, Placebo-controlled IVUS-ACS and ULTIMATE-DAPT trials. | Phase-III | CTS-0072 | Punjab Institute of Cardiology (PIC) Lahore. | - | 12 Months |
| CTS-0066 | Rawalpindi Institute of Cardiology (RIC) Rawalpindi. | ||||||
| CTS-0074 | National Institute of Cardiovascular diseases (NICVD), Karachi. | ||||||
| CTS-0073 | Ch. Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. | #rowspan# | |||||
| 34 | CT-0035 | Double-Blind, Randomized, Placebo-Controlled Trial of High Dose Vitamin D supplementation in the Treatment of Complicated Severe Acute Malnutrition (ViDiSAM). | Phase-II | CTS-0065 | M/s Tehsil Headquarter (THQ), Kahna Nau, Lahore (CTS-0065) | 09th September 2021 | 36 Months |
| CTS-0067 | Department of Social & Preventive Pediatrics situated at M/s Fatima Jinnah Hospital/ Sir Ganga Ram Hospital, Lahore. (CTS-0067) | ||||||
| 35 | CT-0037 | A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase-III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-COV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines. | Phase-III | CTS-0003 | M/s Aga Khan Hospital, Stadium Road, P.O. Box 3500, Karac???hi 74800, Pakistan. | 27th October 2021 | 20 Months |
| CTS-0068 | M/s Dow University of Health Sciences-Ojha Campus, KDA Scheme 33, Gulzar-e-Hijri, SUPARCO Road, Ojha Campus, Karachi, Pakistan. | ||||||
| CTS-0069 | M/s Sindh Infectious Diseases Hospital & Research Center, Near NIPA, University Road, Karachi, Pakistan. | ||||||
| CTS-0048 | M/s Avicenna Dental College, Abdul Waheed Trust, Phase IX, DHA Bedian Road, Lahore. | ||||||
| CTS-0049 | M/s Central Park Teaching Hospital, Ferozpur Road (Kahna Nau), Lahore. | ||||||
| CTS-0026 | M/s Shifa International Hospital Ltd, Pitras Bukhari Rd, H-8/4 H 8/4 H-8, Islamabad, Islamabad Capital Territory. | ||||||
| 36 | CT-0038 | Cluster Randomized-Controlled Study of Home-Based Hepatitis-C, Self-Testing in Karachi, Pakistan, Protocol Number:Asd-05-002. | - | CTS-0003 | M/s Aga Khan Hospital, Stadium Road, P.O. Box 3500, Karac???hi 74800, Pakistan. | 12th January 2022 | 08 Months |