A clinical trial to study activity and safety of Ayurvedic formulation containing Ashwagadha and Haridra in patients freshly diagnosed with Type 2 Diabetes mellitus

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000053

Enrollment

Registered

2008-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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:	—

Measure

Time frame

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

Measure	Time frame
The secondary outcome will be improvement in insulin sensitivity as determined by indices of Insulin sensitivity.Timepoint:	—

Countries

India

Contacts

Public ContactDr. Shilpa Gaikwad

Professor & Head, Dept. of Clinical Pharmacology

urmilathatte@gmail.com022-23014713, 23050347

Outcome results