Clinical Trials Registry

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.NoCT Reg.Title of Clinical Trial / Clinical StudyPhaseClinical Trial Site (CTS)Date of approvalInitial duration
1CT-0001Tranexamic Acid (TXA) For reducing postpartum bleeding in women with Anemia: An International, Randomized, Double Blind, Placebo Controlled Trial Women-II TrialPhase-IIICTS-0001Gynae Unit-I & II, Holy Family Hospital, Said Pur Road. Rawalpindi.18th July 2019.38 Months
CTS-0005Department of Gynae & Obstetrics, Benazir Bhutto Hospital, Rawalpindi.
CTS-0006Gynae Section, Services Institute of Medical Sciences, Lahore.
CTS-0007Department of Gynae & Obstetrics, Nishtar Medical University & Hospital, Multan.
CTS-0008Department of Gynae & Obstetrics, Sir Ganga Ram Hospital, Fatima Jinnah Medical University, Lahore.
CTS-0009Gynae Unit-II,Allama Iqbal Medical College, Jinnah Hospital, Lahore.
CTS-0010Department of Gynae & Obstetrics, Pak-Emirates Military Hospital, Rawalpindi.
CTS-0011Department of Gynae & Obs, Shaikh Zaid Women Hospital, Chandka Medical College, Shaheed Benazir Bhutto Medical University, Larkana.
CTS-0012Department of Gynae & Obstetrics, Federal Govt Poly Clinic Hospital, Islamabad.
CTS-0013Gynae Unit-I & II, Bahawal Victoria Hospital, Bahawalpur.
CTS-0014MCH Unit-II, Pakistan Institute of Medical Sciences (PIMS), MCH Centre, Islamabad.
CTS-0015Dow University of Health Sciences / Dr Ruth Km Pfau Civil Hospital, Karachi.
CTS-0016Gynae Ward-09, Jinnah Postgraduate Medical Centre, Karachi.
CTS-0017Gynae Unit-II, Aziz Bhatti Shaheed Teaching Hospital, Bhimbar Road Gujrat, Nawaz Sharif Medical College, University of Gujrat.
CTS-0023Sandeman Provincial Hospital, Quetta.
CTS-0024Department of Gynae & Obstetrics Bolan Medical Complex, Quetta.
CTS-0025Department of Gynae & Obstetrics Ayub Medical Teaching Institution, Abbotabad.
CTS-0028Gynae Section Koohi Goth Women Hospital, Karachi
2CT-0002Lonafarnib / 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-IIICTS-0003The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi.13th November 2019.24 Months
3CT-0003An 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-IIICTS-0003The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi.12th February 2020.24 Months
CTS-0004Shaukat Khanum Memorial Cancer Hospital, Lahore.
4CT-0004Lactoferrin evaluation in anemia in pregnancy (Leap-1) a multicounty randomized control clinical trial.Phase-IIICTS-0003The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi.15th April 2020.24 Months
5CT-0005endTB (Evaluating Newly Approved Drugs for Multidrug Resistant TB) Phase-III Clinical Trial, At the Indus Hospital Karachi.Phase-IIICTS-0002Ghauri Clinic of the Indus Hospital, Karachi.10th February 2020.60 Months
CTS-0036Institute of Chest Diseases Kotri, Jamshoro, Sindh, Pakistan. (CTS-0036), approval date 24th August 2020.
6CT-0006endTB-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-IIICTS-0002Ghauri Clinic of the Indus Hospital, Karachi.10th February 2020.60 Months
CTS-0036Institute of Chest Diseases Kotri, Jamshoro, Sindh, Pakistan. (CTS-0036), approval date 24th August 2020.
7CT-0007Perioperative Ischemic Evaluation-3 (Poise-3).Phase-IIICTS-0026Shifa Clinical Research Center, Shifa Intonational Hospital Ltd, Islamabad12th February 2020.48 Months
8CT-0008A 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-IVCTS-0030Liaquat University Hospital, Jamshoro.3rd February 2020.24 Months
CTS-0031Sheikh Zaid Hospital, Raheem Yar Khan.
9CT-0009Open-Label Study of Oral Ibrexafungerp (SCY-078) in Patients with Auris-SCY-078-Aga Khan Hospital-Phase-III CT.Phase-IIICTS-0003The Aga Khan University Hospital, Clinical Trial Unit (CTU) Karachi.27th August 2020.132 Days
10CT-0010Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide 60 mg Modified Release Tablet in patients with Type-II diabetes, fasting during Ramadan.Phase-IVCTS-0018Akram Medical Complex, Lahore.12th February 2020.06 Months
CTS-0019Diabetes Institute of Pakistan, Jail Road, Lahore.
CTS-0020National Hospital and Medical Center, Lahore.
CTS-0021Hayatabad Medical Complex (Medical Teaching Institute), Peshawar.
CTS-0027Baqai Institute of Diabetes and Endocrinology, Karachi.
11CT-0011Prevention 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-IIICTS-0029Gynae Department, Jinnah Postgraduate Medical Center (JPMC) Karachi.12th February 2020.36 Months
12CT-0012Heparin Anticoagulation to improve Outcomes in Septic Shock (HALO-Trial)Phase-IICTS-0032The Indus Hospital, Karachi.20th February 2020.36 Months
CTS-0033Mayo Hospital, Lahore.
CTS-0034Dow 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
13CT-0013Colchicine for the Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery" (COP-AF) Protocol No. 2017-001-COPAF.Phase-IIICTS-0026Shifa Clinical Research Center, Shifa International Hospital Islamabad.03rd September 2020.52 Months
14CT-0014Open labelled randomized Phase-I / II Clinical Trial to assess the Safety & efficacy of Iodine Complex (Renessans)Phase-ICTS-0037M/s Lahore General Hospital, Post Graduate Medical Institute, Lahore.20th October 2020.03 Months
15CT-0015Application 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-IIICTS-0003Aga Khan University Hospital, Karachi. 24th August 2020.04 Months
CTS-0002The Indus Hospital, Karachi.
CTS-0004Shaukat Khanum Memorial Cancer & Research Hospital, Lahore.
CTS-0026Shifa International Hospital, Islamabad.
16CT-0016Application 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 & AbovePhase-ICTS-0002The Indus Hospital, Karachi.24th August 2020.56 Days
17CT-0017Effect of Micronutrients and life Skills Education on the Health and Nutrition of Adolescent and young women in Pakistan.Phase-IIICTS-0003The Aga Khan University’s Matiari Research & Training Center, Matiari, Sindh,24th August 2020.48 Months
18CT-0018Capsule Endomicroscopy for visualization of the Small Intestine m EED (Environmental Enteric ln Dysfunction) population Pakistan.CTS-0003The Aga Khan University’s Matiari Research & Training Center, Matiari, Sindh,28th August 2020.29 Months
19CT-0019A 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-IICTS-0002The Indus Hospital, Karachi.25th August 2020.12 Months
20CT-0020Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-l9) in the Healthcare Setting; a Randomized, Placebo controlled Prophylaxis Study (COPCOV)Phase-IIICTS-0003Aga Khan University Hospital, Karachi. 28th August 2020.05 Month
21CT-0021Clinical evaluation of the Panbio COVID-19 Ag Antigen Test in Symptomatic Subjects (CATSS)Phase-IIICTS-0003Aga Khan University Hospital, Karachi. 27th August 2020.04 Months
22CT-0022Immunoglobulin Therapy for Passive Immunization of Critically Ill Covid-19 Patients.Phase-ICTS-0040M/s Dow University Hospital, Dow University of Health Sciences-Ojha Campus,Karachi22nd January 2021.12 Months
CTS-0041M/s Sindh Infectious Diseases Hospital & Research center, Karachi
23CT-0023A 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-IIICTS-0003Aga Khan University Hospital, Karachi.19th March 202103 Months
CTS-0002The Indus Hospital, Karachi
CTS-0020National Hospital & Medical Center, Lahore.
CTS-0004Shaukat Khanum Memorial Cancer Hospital & Research Center, Lahore
CTS-0038University of Health Sciences, Lahore.
CTS-0051Chughtai Laboratory, Lahore.
CTS-0048Abdul Waheed Trust, Avicenna Dental College, Lahore. Avecinna
CTS-0049Central Park Teaching Hospital, Lahore
CTS-0050M/s Aziz Fatima Hospital, Faisalabad.
CTS-0044M/s Al-Shifa Trust Research Center
CTS-0052Clinical Assessment Unit, Examination Unit of M/s Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
24CT-0024A 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-IICTS-0003Aga Khan University Hospital, Karachi.17th March 2021.13 Months
25CT-0026A 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 AdultsPhase-IICTS-0003Aga Khan University Hospital, Karachi. 31st March 2021.84±7 Days
25CT-0027Open-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-IIICTS-0003Aga Khan University Hospital, Karachi. 31st March 2021.222 Days
27CT-0028Randomized, Open Label, Multicenter, Non-Inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica.Phase-IVCTS-0055M/s Mohtarma Shaheed Bhutto General Hospital, Mariabad, Quetta.14th June 202124 Months (Two years or until 832 subjects are recruited for the trial).
CTS-0056M/s Médecins Sans Frontières, Kuchlak Primary Health Center, Quetta.
28CT-0029A Randomized, Double-Blind, Positive Controlled Study to Evaluate Efficacy & Safety of Fuke Qianjin Capsule in Patients with Pelvic Inflammatory Diseases.Phase-IICTS-0046M/s Center for Bioequivalence Studies and Clinical Research (CBSCR), International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, Sindh.17th September 202112 Months
29CT-0030Azithromycin & Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial).-CTS-0061Aga Khan University Hospital for Women, Karim Abad, Karachi.--
CTS-0062Aga Khan University Hospital, Garden East, Karachi. (CTS-0062)
CTS-0063National Institute of Child Health (NICH), Karachi. (CTS-0063)
30CT-0031Anti-Coronavirus Therapies to Prevent Progression of COVID-19Phase-IIICTS-0003Aga Khan University Hospital, Karachi. (CTS-0003)16th July 202112 Months
CTS-0058Tabba Heart Institute, Karachi. (CTS-0058)
CTS-0059Jinnah Postgraduate Medical Center, Karachi. (CTS-0059)
31CT-0032A multicenter, randomized, double-blind, placebo-controlled study to assess safety and efficacy of SIR1-365 in patients with serious Covid-19.Phase-IBCTS-0003Aga Khan University Hospital, Karachi.06th August 202106 Months
CTS-0068Dow University of Health Sciences, Ojha Campus, Karachi.
CTS-0069Sindh Infectious Diseases Institute, Karachi.
32CT-0033A randomized, double-blind controlled clinical trial DWJ1248 in prevention of COVID-19 infection after the exposure of SAR COV-2.Phase-IIICTS-0018Akram Medical Complex, Lahore, 2-B,Main Gulberg, Jail Road Lahore.27th August 202112 Months
CTS-0048Avicenna Hospital, Lahore, Avicenna Dental College, Abdul Waheed Trust, Phase IX, DHA Bedian Road, Lahore.
CTS-0020National Hospital & Medical Center, Lahore. 132/2 St.123, Sector L, DHA Phase-I, Lahore.
33CT-0034Comparison 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-IIICTS-0072Punjab Institute of Cardiology (PIC) Lahore.-12 Months
CTS-0066Rawalpindi Institute of Cardiology (RIC) Rawalpindi.
CTS-0074National Institute of Cardiovascular diseases (NICVD), Karachi.
CTS-0073Ch. Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. #rowspan#
34CT-0035Double-Blind, Randomized, Placebo-Controlled Trial of High Dose Vitamin D supplementation in the Treatment of Complicated Severe Acute Malnutrition (ViDiSAM)”.Phase-IICTS-0065M/s Tehsil Headquarter (THQ), Kahna Nau, Lahore (CTS-0065)09th September 202136 Months
CTS-0067Department of Social & Preventive Pediatrics situated at M/s Fatima Jinnah Hospital/ Sir Ganga Ram Hospital, Lahore. (CTS-0067)
35CT-0037A 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-IIICTS-0003M/s Aga Khan Hospital, Stadium Road, P.O. Box 3500, Karac???hi 74800, Pakistan.27th October 202120 Months
CTS-0068M/s Dow University of Health Sciences-Ojha Campus, KDA Scheme 33, Gulzar-e-Hijri, SUPARCO Road, Ojha Campus, Karachi, Pakistan.
CTS-0069M/s Sindh Infectious Diseases Hospital & Research Center, Near NIPA, University Road, Karachi, Pakistan.
CTS-0048M/s Avicenna Dental College, Abdul Waheed Trust, Phase IX, DHA Bedian Road, Lahore.
CTS-0049M/s Central Park Teaching Hospital, Ferozpur Road (Kahna Nau), Lahore.
CTS-0026M/s Shifa International Hospital Ltd, Pitras Bukhari Rd, H-8/4 H 8/4 H-8, Islamabad, Islamabad Capital Territory.
36CT-0038Cluster Randomized-Controlled Study of Home-Based Hepatitis-C, Self-Testing in Karachi, Pakistan, Protocol Number:Asd-05-002.-CTS-0003M/s Aga Khan Hospital, Stadium Road, P.O. Box 3500, Karac???hi 74800, Pakistan.12th January 202208 Months
LIST OF APPROVED CLINICAL TRIALS AND STUDIES, updated till 30th May,2022