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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 29 June 2014
Main ID:  CTRI/2008/091/000053
Date of registration: 30-04-2008
Primary sponsor: Council of Scientific & Industrial Research, New Delhi
Public title: A clinical trial to study activity and safety of Ayurvedic formulation containing Ashwagadha and Haridra in patients freshly diagnosed with Type 2 Diabetes mellitus
Scientific title: A Proof of Concept prospective, double blind, placebo controlled randomised, multi¬centric study to evaluate the activity and safety of PHP Diabetes in patients freshly diagnosed with Type 2 Diabetes mellitus
Date of first enrolment: 01-05-2008
Target sample size: 60
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=94
Study type:  Interventional
Study design:  Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: Patients satisfying all the following criteria are included in the study:
1. Patients of either sex between the age group 18 to 60 years (both inclusive).
2. Patients who are freshly diagnosed as suffering from Type 2 Diabetes mellitus not on any oral hypoglycemic agent.
3. Patients with HbA1c between 7.0-9.5 %.
4. Patients ready to abide by trial procedures and to give informed consent.

Exclusion criteria: A.1. Patients suffering from any of the following conditions will be excluded from the study:
a. Type 1 diabetes mellitus
b. Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%)
c. Patients with fasting serum cholesterol >260mg% and serum Triglycerides>300 mg%.
d. Patients with HbA1c more than 9.5 %.
e. Patients with ASAT and ALT levels greater than 2.5 times the upper normal limits
f. Severe renal, hepatic or respiratory disorder.
g. Patients with psychiatric disorder.
h. Patients with haematological disorders
i. History of smoking (more than 10 cigarettes/day) or alcohol intake > 20 gm/day.
j. Complications of diabetes such as
_?_ Proliferative type retinopathy
_?_ Nephropathy with laboratory values greater than 1.5 times the upper normal limits
_?_ Presence of ketone bodies in urine analysis
_?_ Ischemic heart disease with any cardiac event in last 6 months
_?_ Fasting serum cholesterol >260mg. % and serum Triglycerides >300 mg%.

2. Patients with BMI >35 kg/m2
3. Patients who are likely to undergo surgery during the study period.
4. Patients who have participated in any investigational study in the last 4 weeks.
5. Patients having known hypersensitivity to the study drugs.
6. Patients with any severe infection
7. Patients with a history of intake of ANY Ayurvedic/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month

B. Pregnant or lactating females and women in child bearing age refusing to use contraceptives.


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Freshly diagnosed Type 2 Diabetes mellitus
Intervention(s)
Intervention1: Tablet PHP-Diabetes containing hydro-alcoholic extracts of Withania somnifera 150mg and Curcuma longa 250 mg: 500 mg BD for 6 months
Control Intervention1: Tablet Placebo: 500 mg BD for 6 months
Primary Outcome(s)
The primary outcome measures will be reduction in HbA1c levels by 0.5% as compared to basal values, reduction in blood sugar (fasting and/or post-prandial) and lipid levels by more than 25% in the group receiving PHP-Diabetes as compared to placebo at the end of three months treatment, improvement in the signs & symptoms score by more than 10% in the group receiving PHP-Diabetes as compared to placebo at the end of three months treatment and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.Timepoint:
Secondary Outcome(s)
The secondary outcome will be improvement in insulin sensitivity as determined by indices of Insulin sensitivity.Timepoint:
Secondary ID(s)
PHP/CSIR/2006/1
Source(s) of Monetary Support
Council of Scientific & Industrial Research, New Delhi
Secondary Sponsor(s)
Indian Institute of Integrative Medicine, Jammu
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