clinical evaluation of Panchtikta Churna in Madhumeha (type 2 Diabetes Mellitus)

Phase 2/3

Not yet recruiting

Registration Number: CTRI/2024/01/061587

Lead Sponsor: Ayurvedic and Unani Tibbia college

Brief Summary: Increasing prevalence of type 2 diabetes mellitus (DM) has become alarming, burdening health care systems throughout the world. According to international diabetes federation in 2005 confirmed that diabetes is one of the most common non- communicable disease globally and constitutes the 4 th or 5th leading cause of death in most developed as well as many developing countries. In India number of estimated cases of diabetes will be 79.4 million by 2030 as compared to 31.7 million in 2000. India is deemed as the worldâ€™s capital of diabetes.In Priya Nighantu(Haritakyadi varga) acharya describes Panchtikta churna is a combination of five medicinal plants having tikta rasa predominately named Saptaparna (Alstonia scholaris bark), Nimba twak ( bark of Azadirachta indica A. Juss.), Rasna (Pluchea lanceolata leaf), Bhunimba ((Andrographis paniculata Nees whole plant) and Patola patra (leaves of Tricosanthes dioica Roxb.) . All these ingredients mainly have Tikta, Kashaya Rasa, Laghu and Ruksha Guna, Katu Vipaka and Ushna Virya. These drugs having Pitta hara, Jwarahara and Swashara properties. Many herbal formulations found effective as hypoglycemic agent in various research studies. Here an attempt is made to arrive at a herbal alternative for diabetes, they are devoid of side effects, can be, collected easily and commonly available, making them very cost effective. Acharya Charak has described Panchtikta Panchaprasratika Basti in siddhi sthan which is used for the treatment of prameha , abhishyand, kustha. In the previous study Panchatikta Panchaprasritika Basti was found effective in diabetic condition . As administration of basti for patients are not very much comfortable and admission required and its effect on glycosylated haemoglobin (HbA1c) was not assessed, so Keeping these facts in mind this study is designed to explore the hypoglycemic effect of Panchatiktachurna in Vitro and on oral administration in patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients of age group 18 to 60 years of either sex.
Fasting plasma glucose â‰¥ 126 mg/dl or Post Prandial glucose level â‰¥ 200 mg/dl.
The HbA1c levels should lie within the range of> 6.5% to <8.5% ( According to American Diabetes Association, ADA ,2022 guidelines).

Exclusion Criteria

Patients having sign and symptoms of complication of Type 2 Diabetes Mellitus like Nephropathy, Retinopathy, Neuropathy.
Patients with gestational diabetes mellitus or pregnant women .
Patients suffering from any chronic diseases such as Bronchial asthma , COPD, Chronic kidney disease , Ischaemic heart diseases , Fatty liver stage 3 and Chronic illness of other body organs , uncontrolled High blood pressure (Systolic more than 160 and diastolic more than 100 mm of Hg) 4.
Patients who are diagnosed with malignancy of any system.
Patients currently using oral hypoglycemic agents (Conventional).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in HbA1c values in patients	3 months

Secondary Outcome Measures

Name	Time	Method
20% decrease in Fasting blood sugar or PP blood sugar or HbA1c.	3 months

Trial Locations

Locations (1): A and U Tibbia College and Hospital
🇮🇳
Central, DELHI, India
A and U Tibbia College and Hospital
🇮🇳Central, DELHI, India
Dr Rishabh Rathore
Principal investigator
8982118464
rishabhrathore06@gmail.com