CTRI/2024/06/068889
Not yet recruiting
未知
A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of Gymne Mag D Capsules in Management of subjects with Type 2 Diabetes Mellitus - NI
M/s Synthite Industries Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- M/s Synthite Industries Private Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Adult male and non\-pregnant females aged 18 to 65 years
- •2 Subjects with HbA1c value \=7\.5 and \=10 percent both inclusive
- •3 Able to comply with all required study procedures and schedule
- •4 Willing and able to give written informed consent.
- •5 BMI less than 35\.0 kg/m2
- •6 Subjects with insufficiently controlled Type 2 Diabetes Mellitus (T2DM) who
- •are inadequately controlled on Metformin Monotherapy greater than or equal to 1000 mg per day for at least 3 months and having inadequate glycemic control
- •7 Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative urine pregnancy test
Exclusion Criteria
- •1 Patient who has Type 1 diabetes mellitus or other forms of diabetes
- •2 Pregnancy or lactation
- •3 Patient who has participated in a clinical study within the last 30 days prior to entering this study
- •4 Subjects with hypersensitivity to any of the ingredients of the study products
- •5 Subjects with a history of acute or chronic illness
- •6 Subjects with history of hypothyroidism and hyperthyroidism
- •7 Subjects with history hyperlipidemia, history of severe hepatic dysfunction or renal dysfunction, uncontrolled pulmonary dysfunction, and poorly controlled hypertension.
- •8 Chronic chewers of tobacco and usage of drugs which exerts intoxication
- •9 History of unstable or rapidly progressing renal disease
- •10 Macroalbuminuria defined as albumin creatinine ratio of greater than 500mg per gm
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
To see the Efficacy and Safety of ProPlus Capsules in patients with Benign Prostatic Hyperplasia (BPH)CTRI/2024/06/068991M/s Synthite Industries Private Limited
Not yet recruiting
Not Applicable
To check the Efficacy and Safety of Ashwagandha DSTR Capsule in patients with Moderate Stress Mild Anxiety Depression Low Stamina and StrengthHealth Condition 1: F430- Acute stress reactionCTRI/2024/06/069402M/s Synthite Industries Private Limited
Not yet recruiting
Not Applicable
To check the Efficacy and Safety of CoQ10 Capsules in patients with OligospermiaHealth Condition 1: N461- OligospermiaCTRI/2024/06/068939M/s Synthite Industries Private Limited
Active, not recruiting
Phase 1
Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.MedDRA version: 21.1Level: LLTClassification code 10050308Term: Iron replacementSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]EUCTR2020-002956-20-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE20
Completed
Phase 3
clinical Study to Evaluate the Efficacy and Safety of test drug in comparison to reference drug in the Treatment of the patients with Hypokalemia.â??Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disordersCTRI/2021/01/030486The ACME LaboratoriesLtd120