ayurveda clinical trials

Six-day clinical trial finds integrative medicine program alters blood serum

Posted on Updated on

Source : University of California – San Diego

Summary : In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experienced measurable decreases in a set of blood-based metabolites associated with inflammation, cardiovascular disease risk and cholesterol regulation.

Image result

In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experienced measurable decreases in a set of blood-based metabolites associated with inflammation, cardiovascular disease risk and cholesterol regulation.

The findings, published in the September 9 issue of Scientific Reports, represent a rare attempt to use metabolic biomarkers to assess the reported health benefits of integrative medicine and holistic practices. Senior author of the study, which included researchers from multiple institutions, was Deepak Chopra, MD, clinical professor in the Department of Family Medicine and Public Health at University of California San Diego School of Medicine and a noted proponent of integrative medicine.

“It appears that a one-week Panchakarma program can significantly alter the metabolic profile of the person undergoing it,” said Chopra, whose foundation provided and managed funding for the study. “As part of our strategy to create a framework for whole systems biology research, our next step will be to correlate these changes with both gene expression and psychological health.”

Study co-author Paul J. Mills, PhD, professor of family medicine and public health and director of the Center of Excellence for Research and Training in Integrative Health, both at UC San Diego School of Medicine, noted that alternative and integrative medicine practices, such as meditation and Ayurveda, are extremely popular, but their effects on the human microbiome, genome and physiology are not fully understood. “Our program of research is dedicated to addressing these gaps in the literature.”

“The researchers looked at the effects of a Panchakarma-based Ayurvedic intervention on plasma metabolites in a controlled clinical trial,” said first author Christine Tara Peterson, PhD, a postdoctoral fellow at UC San Diego School of Medicine. “Panchakarma refers to a detoxification and rejuvenation protocol involving massage, herbal therapy and other procedures to help strengthen and rejuvenate the body.”

The study involved 119 healthy male and female participants between 30 and 80 years of age who stayed at the Chopra Center for Wellbeing in Carlsbad, Calif. Slightly more than half were assigned to the Panchakarma intervention (the Chopra Center’s Perfect Health program, which typically costs $2,865 for a six-day treatment). The remainder to a control group. Blood plasma analyses, using liquid chromatography and mass spectrometry, were taken before and after the six-day testing period.

The researchers found that in the Panchakarma group there was a measurable decrease in 12 specific cell-membrane chemicals (phosphatidylcholines) correlating with serum cholesterol and inversely related to Type 2 diabetes risk.

“These phospholipids exert broad effects on pathways related to inflammation and cholesterol metabolism,” said Peterson. “Plasma and serum levels of the metabolites of phosphatidylcholine are highly predictive of cardiovascular disease risk.”

Application of a less stringent measurement standard identified 57 additional metabolites differentially abundant between the two groups of participants. The authors suggested that given the very short duration of the trial, the serum profile changes were likely driven by the vegetarian diet component of Panchakarma. They said further studies were needed to more fully understand the processes and mechanisms involved.

Story Source:

The above post is reprinted from materials provided by University of California – San Diego. Note: Content may be edited for style and length.

Journal Reference:

  1. Christine Tara Peterson, Joseph Lucas, Lisa St. John-Williams, J. Will Thompson, M. Arthur Moseley, Sheila Patel, Scott N. Peterson, Valencia Porter, Eric E. Schadt, Paul J. Mills, Rudolph E. Tanzi, P. Murali Doraiswamy, Deepak Chopra. Identification of Altered Metabolomic Profiles Following a Panchakarma-based Ayurvedic Intervention in Healthy Subjects: The Self-Directed Biological Transformation Initiative (SBTI). Scientific Reports, 2016; 6: 32609 DOI: 10.1038/srep32609

Source: 1

Types of Clinical Research – Based on Investigational Product

Posted on Updated on

Learn Clinical Research with AuroBlog

Types of Clinical Trials – Based on Investigational Product.

Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way  different from the approved form, or when used for an unapproved indication, or when used to gain further  information about an approved use.

In simple terms – Investigational Product or IP is the medicine/treatment on which a clinical trial is conducted. Based on what Investigational Product is used, clinical trials can be classified as follows.

Chemical Entity Clinical Trials.

These are clinical trials conducted on Allopathy medicines. Chemical Entities can be NCE (New Chemical Entity) which means a newly discovered Allopathy medicine. They can also be FDC (Fixed Dose Combination) i.e. combinations of various drugs in one tablet – multiaction tablets.

Medical Devices Clinical Trials.

As per CDSCO, Medical Devices can be classified as follows based on risk.

Class A: Low Risk: Eg: Thermometers, Tongue depressors.

Class B: Low-Moderate Risk: Eg: Hypodermic needles.

Class C: Moderate -High Risk: Eg: Bone fixation Plate

Class D: High Risk: Eg: Heart Valves, Defibrillators, Stents.

Clinical trials on medical devices are predominantly conducted for BIOCOMPATABILITY – how the human body reacts or accepts a foreign body which is intending to diagnose, treat or manage a disease or disorder.

AYUSH Clinical Trials:

Clinical trials on Ayurveda, Siddha, Homeopathy, Naturopathy, can be done on both medicines, cosmetics and even supplements.

Vaccine Clinical Trials:

Vaccine clinical trials can be of two types.

Prophylactic: Developing a new vaccine and doing clinical trial on the vaccine to verify if it prevents a disease or disorder.

Therapeutic: Sometimes attentuated vaccines maybe given as a way of boosting the body’s immune system against a particular disease.

Biologics Clinical Trials:

Clinical trials on medicines or treatments that are derived from biological sources. Eg: Stem cells, Monoclonal antibodies, gene therapy etc.

Clinical Trials on Treatment Systems:

Clinical trials may be done to verify the efficacy and safety of a change in a particular treatment modality. Eg: A new surgical methodology development, cross interaction treatments between different systems of medicine or even developing new treatment systems such as acupressure, acupuncture etc.

Ask Aurous