A clinical study to see the effect of some Ayurvedic formulations in the patients of Type II Diabetes Mellitus.

Phase 2

Recruiting

• Conditions: Type-II Diabetese Mellitus

• Registration Number: CTRI/2014/05/004613
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

The Central Council forResearch in Ayurvedic Sciences (CCRAS) is an autonomous body under theDepartment of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha andHomeopathy), Ministry of Health & Family Welfare, Government of India.CCRAS is an apex body in India for the formulation, co-ordination,development and promotion of research on scientific lines in the Ayurvedasystem of medicine.

Aimed at generatingevidence for the scientific validation of the clinical efficacy  and  safety  of  classical  Ayurvedic  formulations,multicentreclinical trials have been initiated in peripheral institutes of theCouncil as an activity under the Intra Mural Clinical Research (IMR)programme.

**Nisha Katakadi Kashaya**is a poly herbal preparationcontaining: Nisha(*Curcuma longa*),Kataka(*Strychnos potatorum*),Dhatri(*Emblica officinalis*),Lodhra(*Symplocusracemosa*),Paranti(*Ixora coccinea*),Bhadraka(*Aerva lanata*),Meharimula(*Salacia reticulate*),Ushira(*Veitiverazizanoides*).

**Yashada Bhasma**iscalcined preparation of Zinc.

The present studyentitled **“Clinical Evaluation of Nisha Katakadi Kashaya and YashadaBhasma in the Management of Type II Diabetes Mellitusâ€**is beingundertakenin four peripheral institutes of the CCRAS.

The cumulative evidencegenerated as an activity under the IMR programme is expected to scientificallysubstantiate the claims regarding clinical efficacy and safety of theseclassical Ayurvedic formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-14

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients who are diagnosed to be Type II Diabetics by either HbA1c >6.5%.
• or BS-F>126 mg% of BS-PP >200 mg% / Diabetics who are on lifestyle modification & /or on Tab.Metformin upto 2gm/ day.
• Willing to participate in clinical trial.

Exclusion Criteria

• Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
• Patients suffering from Type-I / brittle diabetes mellitus.
• Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
• Patient with poorly controlled Hypertension (>140 / 90 mm Hg).
• Patient with poorly controlled Gycemic status(HbA1c>8 %).
• Symptomatic patient with clinical evidence of Heart failure.
• Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
• Pregnant / Lactating women.
• Patient on steroids, oral contraceptive pills or estrogen replacement therapy.
• Alcoholics and/or drug abusers.
• Patients with evidence of malignancy.
• H/o hypersensitivity to any of the trial drugs or their ingredients.
• Patients who have completed participation in any other clinical trial during the past six (06) months.
• Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Blood Sugar Fasting(10-12 hours after dinner)	Change in Blood Sugar Fasting(10-12 hours after dinner)

Secondary Outcome Measures

Name	Time	Method
Change in the SF-36-Health Survey Score	At Baseline,at 84th day and at the end of follow
Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ)	At Baseline-84th day and at the end of follow up
Change in Glycosylated haemoglobin (HbA1c%)	At Baseline and 84th day
Change in Blood sugar Post -Prandial. (100-120	minutes after breakfast)

Trial Locations

Locations (4)

Ayurveda Regional Research Institute, Mandi; 🇮🇳 Mandi, HIMACHAL PRADESH, India

Dr.Achanta Lakshmipati Research Center for Ayurveda,Chennai.; 🇮🇳 Chennai, TAMIL NADU, India

National Ayurveda Research Institute for Vector Borne Disease, Vijayawada; 🇮🇳 Krishna, ANDHRA PRADESH, India

National Research Institute for Panchkarma, Cheruthuruthy; 🇮🇳 Thrissur, KERALA, India

Ayurveda Regional Research Institute, Mandi

🇮🇳Mandi, HIMACHAL PRADESH, India

Dr S K Sharma

Principal investigator

01905222857

arri.mandi@gmail.com