Comparative study of Chitraktriphladi Kashayam with madhu and Chitraktriphladi Kashayam Ghana vati in Diabetes.

Phase 2/3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2021/05/033681
• Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary

**AIMS& OBJECTIVES:**

*1.*To assess clinical efficacy of *Chitraktriphladi Kashayam with Madhu* inthe management of a series of patients suffering from *Madhumeha (DM Type II).*

2.     To assess clinical efficacy of *Chitraktriphladi Kashayam Ghana Vati* inthe management of a series of patients suffering from *Madhumeha* (DM Type II).

To compare theefficacy of *Chitraktriphaladi Kashayamwith Madhu and Chitraktriphaladi Kashayam Ghana Vati* in the management of *Madhumeha* (DM Type II).

**HYPOTHESIS**

**Nullhypothesis [H0]:**

*Chitraktriphaladi Kashayamwith Madhu* and *ChitraktriphaladiKashayam Ghana Vati* are equally effective in the Management Of *Madhumeha* (Type-2 Diabetes Mellitus).â€

**MATERIALS &METHODS**

Following materials and methods will be employedfor conducting the present research    work-

**CLINICAL STUDY**

Following materials andmethods will be employed for conducting the present research work-

**Selection of Cases:**

§  Thestudy will be conducted in 30 clinically diagnosed and confirmed patients of *Madhumeha* (Type II Diabetes Mellitus)from OPD/IPD of NIA hospital, Jaipur. These patients will be randomly dividedinto two groups - Group A, Group B with 15

patients in each group.

**DiagnosticCriteria**

§  Diagnosis basedon presenting clinical features of *Madhumeha*(Type II DM).

§  Subjects with FBS> 126 mg/dl, PPBS > 140-300 mg/ dl

**StudyDesign:**

The present study issupposed to be-

·        **Level of study** : OPD/IPD

·        **Study type** : Interventional,Single Centre

·        **Purpose** : Treatment

·        **Masking** : Open Label

·        **Timing** : Prospective

·        **End point** : Safety and efficacy

·        **No. of groups** : Two (15patients in each group)

**No. ofpatients** 30

·        **Duration of Study** : 30 days

·        **Follow-up** : 15thday, 30th day after initial assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Last Update Posted: 2021-09-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Patients giving the clinical history of DM (Type II).
• 2.Patients having hyperglycaemia confirmed by laboratory investigations i.e. Fasting Blood Sugar (FBS) ≥ 126mg/dl or Post Prandial Blood Sugar (PPBS) ≥ 140-300 mg/dl 3.Presence of Cardinal symptoms of Diabetes Mellitus eg.
• (3P- polyuria, polydypsia, polyphagia).

Exclusion Criteria

• i.Patients below 30 years of age & above 70 years of age.
• ii.Patients having Type I DM.
• iii.Patients of Type II DM who are on insulin therapy.
• iv.Patients having any serious illness like Coronary Artery Disease, malignancy, hypertension > 140/90 mm of Hg 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
Changes in Cardinal Symptoms of Type -II Diabetes Mellitus ( Madhumeha )	30 Days

Secondary Outcome Measures

Name	Time	Method
Changes in the objective parameters.	30 Days

Trial Locations

Locations (1)

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

National Institute of Ayurveda and Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Parveen Sharma

Principal investigator

9068000101

drparveensharma44@gmail.com