To See the efficacy of Katankateryadi kwatha and Indra Vati in the management of Madhumeha (Diabetes mellitus)

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/06/019627
• Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary

**Aims and Objectives:***To assess the efficacy of* *Katankateryadi Kwatha* and *Indravati* *in the management of Madhumeha* *(DM Type II).***Selection of Cases:** Study will be conducted in 45 clinically diagnosed and confirmed patients of *Madhumeha (Type II Diabetes Mellitus)* from OPD/IPD of *Arogyashala* NIA, Jaipur. These patients will be randomly divided into three groups - Group A, Group B and Group C with 15 patients in each group.

**Study Design:**Open label, Randomized, Single Centre

**Administration of Drug:**

Patients in Group A will be administered Trial Drug *Katankateryadi Kwatha* in the dose of 50 ml BD before meal for 30 days.

·         Patients in Group B will be administered *Indra Vati* 125 mg twice a day after meal for 30 days with luke warm water.

Patients in Group C will be administered both *Katankateryadi Kwatha* and *Indra Vati* for 30 days.

**Criteria for Assessment:**

The effect of trial drug will be assessed in following subjective and objective parameters -

**Subjective Parameter:***Prabhoot mutrata* (Polyuria), *Kshudhadhikya* (Polyphagia), *Trishnadhikya* (Polydypsia),  *Klama* (Early Fatigue), *Mukha Shosha* (Dryness of mouth), *Vibandha* (Constipation), *Kara pada daha* (Burning sensation in hands and feet),  *Hasta pada and sandhi shoola* (Pain in hands, feet and joints), *Kara pada supti* (Numbness of hands and feet), *Daurbalya* (Weakness)

**Objective Parameter:**Complete Blood Count (C.B.C.), Erythrocyte sedimentation rate (E.S.R), Fasting Blood Sugar (F.B.S), Post Prandial Blood Sugar (P.P.B.S), Glycosylated Hemoglobin (HbA1c), Blood Urea, Sr. Creatinine, S.G.P.T and S.G.O.T, Lipid Profile, Urine Examination-Routine and Microscopic examination.

**Routine Examination & Assessment:**

The full details of history & physical examination of patient will be recorded as per the Performa. Clinical assessment will be done on 1st day, 15th day and 30th day.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-18
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• i.Patient willing to sign the consent form.
• ii.Patients between the ages of 30-70 years of either sex.
• iii.Patients giving the clinical history of DM (Type II).
• iv.Patients having hyperglycemia confirmed by laboratory investigations i.e. Fasting Blood Sugar (FBS) ≥ 126mg/dl or Post Prandial Blood Sugar (PPBS) ≥ 200mg/dl or Glycosylated Hemoglobin (HbA1c) ≥ 6.5%.
• v.Presence of Cardinal symptoms of Diabetes Mellitus eg.
• (3P- polyuria, polydypsia, polyphagia).

Exclusion Criteria

• i.Patients below 30years of age & above 70 years of age.
• ii.Patients having Type I DM.
• iv.Patients having any serious illness like Coronary Artery Disease, malignancy, etc.
• v.Drug induced DM.
• vi.F.B.S. > 200 mg/dl and P.P.B.S. > 300 mg/dl.
• vii.Patients having chronicity of more than 5 years.
• viii.DM with complications.
• ix.Pregnant and lactating mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of changes in	30 days for Each Patients
specific signs and symptoms of Madhumeha and Type II Diabetes Mellitus	30 days for Each Patients

Secondary Outcome Measures

Name	Time	Method
Any adverse effect in the	values of haematological test and in clinical

Trial Locations

Locations (1)

National Institute of Ayurveda Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Deepak Suman

Principal investigator

7568396094

drdeepaksuman11@gmail.com