CTRI/2019/06/019516尚未招募2 期
An open label single arm clinical study to evaluate the safety and efficacy of PR/HC/17-18/003 formulation for weight management in obese or overweight patients. - Nil
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Male and or female patients.
- •2 Age between 20 to 50 years.
- •3 BMI between 25 to 40 kg/m2.
- •4 Willing to come for regular follow-up visits.
- •5 Able to give written informed consent.
排除标准
- •1 Intake of over the counter weight loss agents, centrally acting
- •appetite suppressants in the previous six months.
- •2 Pathophysiologic/ genetic syndromes associated with obesity
- •(Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome).
- •3 Patients with evidence of malignancy.
- •4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).
- •5 Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg).
- •6 Patients on prolonged ( > 6 weeks) medication with corticosteoids,
- •antidepressants, anticholinergics, etc. or any other drugs that may
- •have an influence on the outcome of the study.
- •7 Symptomatic patient with clinical evidence of Heart failure.
- •8 Patients with concurrent serious hepatic disorder (defined as
- •Aspartate Amino
- •Transferase (AST) and / or Alanine Amino Transferase (ALT), Total
- •Bilirubin,Alkaline Phosphatase (ALP) > 2 times upper normal limit) or
- •Renal Disorders (defined as S.Creatinine >1.2mg/dL), Severe
- •Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or
- •Chronic Obstructive Pulmonary Disease [COPD]), or any other
- •condition that may jeopardize the study.
- •9 History of HIV and other viral infections.
- •10 Alcoholics and/or drug abusers.
- •11 Prior surgical therapy for obesity.
- •12 History of hypersensitivity to any of the herbal extracts or dietary
- •supplement.
- •13 Pregnant / lactating woman.
- •14 Patients who have completed participation in any other clinical
- •trial during the past six (06) months.
- •15 Any other condition which the Principal Investigator thinks may
- •jeopardize the study
研究者
相似试验
招募中
4 期
To check the effect of Migraine -XS tablet in patients having MigraineCTRI/2023/02/049929M Global Nutraceuticals
尚未招募
3 期
An open label single arm clinical study to evaluate the effect of kalyanaka guda in sutika panduCTRI/2023/06/054034Dr Supriya
已完成
3 期
Evaluating the efficacy of Kasantaka Churna with Madhu in the management of Kaphaja kasa w.s.r to Chronic Bronchitis : A Clinical trialCTRI/2023/03/050456Dr Mohammad Aamir40
尚未招募
2 期
To study the effectiveness of virechana(purgation therapy)in Hypothyroidism.CTRI/2021/04/032810Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
已完成
不适用
Role of Shalmali Moola Granules to Increase Sperm countCTRI/2019/11/021980Parul Institute Of Ayurveda30