A clinical trial to study the effects of Phalatrikadi kwath and Madhugrit in patients with Type 2 Diabetes Mellitus.

Phase 2/3

Not yet recruiting

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

• Registration Number: CTRI/2023/10/058246
• Lead Sponsor: Patanjali Bhartiya Aryuvigyan evam Anusadhan Santhan

Brief Summary

This study is a Open Label, Double Arm  Comparative study, comparing the efficacy of Phalatrikadi kwath 40ml twice daily before meal and Madhugrit each 550mg 2 tablets twice daily after meal for 18 months in 40 patients with madhumeha roga that will be conducted in Opd no. 13/14 in Patanjali Ayurvedic Hospital, Haridwar.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-10
• Study Start: 2023-10-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Participants will be selected irrespective of gender and socio-economic status.
• 2.Patients aged between 30 – 65 years.
• 3.Participants fulfilling the signs and symptoms of Madhumeha.
• Prabhutmutrata (Polyuria) b.
• Kar-pada daha (Burning sensation in hands and feet) c.
• Kantha taalusosha (polydipsia) d.
• Availa mutrata (Turbid urine) e.
• Angasaad (Fatigue) f.
• Mukha Madhuryasyata (Sweet taste of mouth) g.
• Daurgandhaya (Foul smell) h.
• Blood glucose level i.
• Fasting Blood glucose from 126mg/dl to 200 mg/dl j.
• Post-Prandial Blood glucose from 200 mg/dl to 300 mg/dl k.

Exclusion Criteria

• Patients with Type I Diabetes (Juvenile Diabetes) 2.
• Patients who are taking insulin.
• Diabetes Mellitus with Hypertension, other endocrinological diseases and any other systemic disease.
• Diabetes Mellitus with complications such as Retinopathy, Nephropathy and Diabetic foot 6.
• Pregnancy and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Prabhoot-mutrata (Polyuria - frequency of urination)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
Subjective parameters	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
2.Kanth taalu shosh (Polydipsia – the feeling of thirst)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
3.Angsaad (Fatigue)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
Objective parameters	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
4.Avilmutrata (turbid urine)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
5.Mukha – madhuryata (sweet taste of mouth)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
6.Daurgandhaya (foul smell)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
7.Karpada-daha (burning sensation in hand and feet)	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
The objective assessment will be done on the basis of changes in the following	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
•Fasting Blood glucose	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
•Post-Prandial Blood glucose	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
•Lipid Profile	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days
•Urine test for glucose	0 days, 30 days, 60 days, 90 days | HbA1c – | Time point - 0 days and 90 days

Secondary Outcome Measures

Name	Time	Method
Objective parameters	The objective assessment will be done on the basis of changes in the following

Trial Locations

Locations (1)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan

🇮🇳Hardwar, UTTARANCHAL, India

Dr Paridhi Painuly

Principal investigator

8958757958

paridhipainuly123@gmail.com