A Randomised Controlled Study of Kampilladi churna in Diabetes Mellitus Type II (Madhumeha)

A Randomised Controlled Trial To Evaluate The Efficacy Of Kampilladi Churna In The Management Of Madhumeha W.S.R. To Diabetes Mellitus Type II. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076677

Enrollment

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Subject with age between 30 to 70 years of both sexes. 2) Newly diagnosed patients of Type II Diabetes Mellitus fulfilling criteria of diagnosis having 50% and more than 50% of cardinal signs and symptoms of Madhumeha. 3) Subject with fasting blood sugar between 126-200 mg/dl. 4) Subject with post meal blood sugar between 200-250 mg/dI. 5) Subject with HbA1c between 6.5- 8%. 6)Patients with Controlled Hypertension with medications (on drugs), fulfilling above criteria of diagnosis of Type II Diabetes Mellitus (Madhumeha) 7)Subject who is willing ready to participate in the research project

Exclusion criteria

Exclusion criteria: 1) Subject with complications of Diabetes Mellitus (Type II). 2) Pregnant and lactating women. 3) Subjects with multiple endocrine disorders, malignancy or other systemic illness affecting blood sugar level. 4) Participate in other clinical trial.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the clinical efficacy of Kampilladi churna in the management of Madhumeha w.s.r. to Diabetes mellitus type II. Blood sugar will be assessed by Objective criteria will be assessed by glucometer i.e FBS AND PBS every 15 days and HbA1C will be assessed on 0th day and 90th day 2. To study the etiopathology of Madhumeha w.s.r. to Diabetes mellitus type II.Timepoint: Follow up of Fbs and Pbs is at 0th,15th,30th ,45th,60th ,75th ,90th day Hba1c at 0th day and 90 th day Final assessment on 90th day	—

Measure

Time frame

1.To evaluate the clinical efficacy of Kampilladi churna in the management of Madhumeha w.s.r. to Diabetes mellitus type II. Blood sugar will be assessed by Objective criteria will be assessed by glucometer i.e FBS AND PBS every 15 days and HbA1C will be assessed on 0th day and 90th day 2. To study the etiopathology of Madhumeha w.s.r. to Diabetes mellitus type II.Timepoint: Follow up of Fbs and Pbs is at 0th,15th,30th ,45th,60th ,75th ,90th day Hba1c at 0th day and 90 th day Final assessment on 90th day

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Secondary

Measure	Time frame
1.Subjevtive criteria of madhumeha will be assessed by scoring pattern developed by Guddoye and Vyas– 1) Mukhamadhurya(sweetness in mouth) 2) Karpadasupti(numbness in palm and foot) 3) Dantadinammaladhikya(infection)[43] 4) Nidradhikya(excess sleep) 5) Pipasavriddhi(polydipsia) 6) Mutradhikya(polyuria)[43] 7) Swedadhikya(excess perspiration) 8) Karpadadaha(burning sensation in palm and foot) 9) Alasya(general debility) 10) Kshudhadhikya (increase in appetite) 11) Daurbalata (weakness) 2. To study the literature of Diabetes mellitus type II from modern point of view and from different ayurvedic SamhitasTimepoint: 90 days Follow up at every 15 days 0th,15th,30th,45th,60th ,75th ,90th day Final assessment on 90th day	—

Measure

Time frame

1.Subjevtive criteria of madhumeha will be assessed by scoring pattern developed by Guddoye and Vyas– 1) Mukhamadhurya(sweetness in mouth) 2) Karpadasupti(numbness in palm and foot) 3) Dantadinammaladhikya(infection)[43] 4) Nidradhikya(excess sleep) 5) Pipasavriddhi(polydipsia) 6) Mutradhikya(polyuria)[43] 7) Swedadhikya(excess perspiration) 8) Karpadadaha(burning sensation in palm and foot) 9) Alasya(general debility) 10) Kshudhadhikya (increase in appetite) 11) Daurbalata (weakness) 2. To study the literature of Diabetes mellitus type II from modern point of view and from different ayurvedic SamhitasTimepoint: 90 days Follow up at every 15 days 0th,15th,30th,45th,60th ,75th ,90th day Final assessment on 90th day

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Countries

India

Contacts

Public ContactDr Bhumika Rajai

Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Nandanwan,Nagpur

ctanmane@gmail.com9422174598

Outcome results