To study the combined effect of Panchakarma and Oral medicine in the management of in Type 2 Diabetes Mellitus

Not yet recruiting

• Conditions: Sthoola Madhumeha and Type 2 Diabetes Mellitus; Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2020/06/026223
• Lead Sponsor: Dr Prakash V Naraboli

Brief Summary

Madhumeha is one among the Vataja Prameha that has been considered as Mahagada1. Sthoola Madhumeha is Tridoshajanya, Atisantarpanajanya, Keldaudbhajanya Vyadhi. It is Yapya vyadhi because of Saptadushya and Apara ojus involved2,3,4.

Sthoola Madhumeha is having extensive etiological factors like improper food habits, genetic, life style etc.. Sthoola Madhumeha is of two types viz.. Avaranajanya and Dhatu kshayajanya Sthoola Madhumeha5,6,7. On the basis of Nidana Panchaka, Avaranjanya Sthoola Madhumeha can be corelated to Non Insulin Dependent Diabetes Mellitus (NIDDM)8,9

Diabetes Mellitus has emerged as a global health hazard and is having tremendous socio-economic impact to the individual as well as society as awhole. According to international diabetic federation (IDF) in the year 2014, worldwide about 387 million people were afflicted with Diabetes, the majority of which are aged between 40 and 59, and 80% of them live in low and middle income countries. According to a study carried out in the year 2013 by the Indian council of medical research, India has 62.4 million people with Diabetes, out of which 90% have Type II Diabetes Mellitus10,11.

Type II Diabetes Mellitus is a heterogeneous disorder with varying prevalence among different ethnic groups. The pathophysiology of T2DM is characterized by peripheral insulin resistance, impaired regulation of hepatic glucose production and declining β-cell function, eventually leading to β-cell failure12,13.

As Atisantarpana is pradhana nidana for Sthoola Madhumeha, Apatarpana chikitsa is pradhana chikitsa siddhanta which includes Vamana, Virechana, Basti, Shamanaushadis and Rasayana. Udvartana, Abhyanga, Swedana, Seka and many Bahirparimarjana chikitsa are few contemporary treatment modalities for Sthoola Madhumeha14,15,16.

Udvartana having qualities like Rukshana, Lekhana, Kledahara, hence it is considered as best line of treatment for Sthoola Madhumeha17,18.

Panchatikta Panchaprasrutika Basti helps to manage impaired metabolic condition by impacting equilibrium state of dosha, nourishing the dhatu and maintain thereby blood sugar level19,20,21.

Nishamalaki Yoga with its gunas laghu, ruksha, tikta rasa, Usna veerya as well as Rasayana effect helps to treat Sthoola Madhumeha22,23. Keeping the above protocol in mind, here in an effort is made for holistic approach towards Sthoola Madhumeha by evaluating the combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga.

Hence this study is aimed to Evaluate the Combined Efficacy of Udvartana, Panchatikta Panchaprasrutika Basti and Nishamalaki Yoga in the management of Sthoola Madhumeha with special reference to Type II Diabetes Mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-08
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients present with classical signs & symptoms of Sthoola Madhumeha (Type II Diabetes Mellitus) of 6 months and FBS ranging between 120mg/dl to 180mg/dl and PPBS ranging between 160mg/dl to 300mg/dl.
• Patients between the age group of 40 to 60 years.
• Patients having Sthoola Madhumeha and BMI > 30kg/m2 4.
• Patients irrespective of religion, sex, socio-economic status, occupation etc.
• Patients who are fit for Udvartana and Basti.
• Patients who are willing to sign the informed consent.

Exclusion Criteria

• Patients with diagnosed cases of Sahaja and Dhatukshayajanya Sthoola Madhumeha.
• Patients of Type II Diabetes Mellitus under Insulin treatment and anti diabetic medicines.
• Patients associated with any Endocrine metabolic disorders and complications.
• Pregnancy and Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga.	60 days

Secondary Outcome Measures

Name	Time	Method
Hence this study is aimed to Evaluate the Combined Efficacy of Udvartana, Panchatikta Panchaprasrutika Basti and Nishamalaki Yoga in the management of Sthoola Madhumeha with special reference to Type II Diabetes Mellitus. Keeping the above protocol in mind, here in an effort is made for holistic approach towards Sthoola Madhumeha by evaluating the combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga	4 weeks

Trial Locations

Locations (1)

BVVS Ayurved Medical College and Hospital; 🇮🇳 Bagalkot, KARNATAKA, India

BVVS Ayurved Medical College and Hospital

🇮🇳Bagalkot, KARNATAKA, India

Dr Prakash V Naraboli

Principal investigator

8867175234

ayushprakash11@gmail.com