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Clinical Trial Protocol for Herbal Drugs
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
The Central Council for Research on Ayurvedic Sciences (CCRAS) is the main regulatory body in India for conducting clinical trials with various Ayurvedic drugs, including medicinal plants following the standard guidelines. The CCRAS has identified 1690 clinical trials on medicinal plants from outside the India, while there are 102 studies on medicinal plants at the combined level of fundamental and clinical trials in India (India 2015).
International clinical research and the problem of benefiting from injustice
Published in Erik Malmqvist, Kristin Zeiler, Bodily Exchanges, Bioethics and Border Crossing, 2015
About a year later, Sam comes across an in-depth newspaper article about his new drug. The article describes how the drug was developed through a series of clinical trials in India and other Asian countries. It is revealed that some of the subjects in the early-stage trials were desperately poor and chose to participate in pursuit of the modest financial reward. Some of the subjects in the late-stage trials were asthmatics who chose to participate because they had no other way of receiving treatment for their condition. Reading the story evokes strong moral discomfort in Sam. He is deeply concerned by the poverty and lack of access to healthcare among those who participated in the trials. What is especially disturbing, however, is the sense of being personally linked to these circumstances. Sam feels vaguely connected to the distant people on whom the drug was tested, as if the fact that he has benefited from the drug makes him in some sense responsible for their plight.
The need for liberal regulations for promoting evidence-based Ayurveda
Published in C. P. Khare, Evidence-based Ayurveda, 2019
PART X A: 122 DAC. Permission to conduct clinical trial: (1) The Licensing Authority as defined in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely: Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations;Approval of the Ethics Committee shall be obtained before initiation of the study;Clinical trial shall be registered at Clinical Trials Registry of India before enrolling the first patient for the study;Annual status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority and in case of termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority;Any report of serious adverse event occurring during clinical trial to the subject, after due analysis, shall be forwarded within ten days of its occurrence as per Appendix XI and in compliance with the procedures prescribed in Schedule Y.
Effect of holistic relapse prevention intervention among individuals with alcohol dependence: a prospective study at a mental health care setting in India
Published in Journal of Ethnicity in Substance Abuse, 2022
Sreevani Rentala, Siu-Man Ng, Cecilia L. W. Chan, Prasanth Bevoor, Raghavendra Bheemappa Nayak, Mahesh Desai
The trial was approved by the Institutional ethics committee and clinical trials registry-India (CTRI/2018/07/014994). Trial was conducted from May 2018 to November 2019. All patients who met the inclusion criteria were invited to participate in the study. 185 patients were found eligible to take part in the study of which 159 agreed to participate and gave their written consent. The participants were then randomly allocated to either of the I-BMS or TAU groups with the help of computer generated random sequence numbers. Forty nine participants withdrew amidst the study without completing the scheduled sessions. Eighteen of these participants were from I-BMS group and the remaining thirty one from the TAU group. Thus, the effective sample size of the study was 100 (50 in each group). Flow chart (Figure 1) depicts the number of participants recruited and completed the RCT.
Clinical Trial Access in Low- and Middle-Income Countries: A Case Study on India
Published in Cancer Investigation, 2021
Aakash Desai, Bhawna Sirohi, Aju Mathew
India has 16% of global population and 20% of the global disease burden. India should have been a powerhouse for clinical trials with its large population, vastly trained manpower, several centers of biomedical excellence, and a pharmaceutical industry that has gained global acclaim as the ‘pharmacy of the World’. Despite this, the proportion of global clinical trials conducted in India is merely 1.2% (6). An audit on cancer clinical trials using the Clinical Trial Registry of India (CTRI), found that of the total 559 studies conducted over 10 years, only 350 were interventional trials (data on file) (7). Of these 30% (99 trials) were conducted in Breast cancer, 15% (49 trials) in lung cancer, 14% (47 trials) in head and neck cancer, 12% (39 trials) in multiple tumor types, including hematological, and 10% (32 trials) in gynecological malignancies. Of these, 68% trials were conducted only in India while 32% of trials were conducted in India as part of a multinational study. 49% of these conducted trials were found to be industry sponsored. This exemplifies the major barriers to access to clinical trials in India and possibly other LMICs. Three of four cancer patients may be affected by structural and clinical barriers to trial participation (8). In the Indian subcontinent, this is largely caused due to the regulatory landscape.
Effect of Cholecalciferol Supplementation on Treatment Response and IL-10 Level in Vitamin D Deficient Parthenium Dermatitis Patients: A Randomized Double-Blind Placebo-Controlled Trial
Published in Journal of Dietary Supplements, 2020
Alphienes Stanley Xavier, Sandhiya Selvarajan, Laxmisha Chandrasekar, Sadishkumar Kamalanathan
The study protocol was approved by the Institutional Ethics Committee (JIP/IEC/2015/20/725) and the trial was prospectively registered with Clinical Trials Registry - India (CTRI/2016/02/006626). Patients attending eczema clinic at the outpatient Department of Dermatology, JIPMER, were screened for eligibility during the study period from March 2016 to December 2017. Clinically diagnosed Parthenium dermatitis patients of either gender, age between 30 and 60 yrs, with serum vitamin D level between 10 and 20 ng/ml, and to be started on systemic treatment with azathioprine were included in the trial. Pregnant and lactating women, individuals already on vitamin D supplementation, patients who had participated in other trials within the past 3 months, and individuals with liver or renal dysfunction were excluded.