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A Clinical Trial to Study the Effect of Salsaradi Gana Bhavit Haritaki in Patients with High Glucose Levels in Blood.

Phase 2/3
Completed
Conditions
Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,
Registration Number
CTRI/2023/07/054652
Lead Sponsor
Government Akhandanand Ayurveda College, Ahmedabad
Brief Summary

India has an estimated 77 million people with Diabetes, which makes it the second most affected in the world, after China. One in six people (17%) in the world with diabetes is from India. Diabetes is one of the most challenging diseases for medical science to cure like other systemic diseases, as it has more serious complications due to negligence in management.

Modern medical science treats the condition with Oral hypoglycemic agents and Insulin to manage high blood sugar levels. The patient must take medicines to control blood sugar levels for a lifelong period. Though high blood sugar levels are managed by oral hypoglycemic agents and insulin, long-term use can cause many side effects like GI discomfort, heartburn, polyuria, etc. Hence, there is a scope for *Ayurveda* treatment for the management of high blood sugar levels.

The drugs in the trial formulation have been described by *Acharya **Sushruta*** collectively as ***Salasaradi Gana*** having action by their ***Kapha – Medoshoshan*** properties .

***Haritaki*** is mainly of ***Kasaya Rasa, Ushna, Ruksa Guna***. It acts as ***Kaphgna***, these qualities of ***Haritaki*** acts as a cleanser and it also improves digestion. Same as in Diabetes (Prameha) there is ***Dusti*** of ***Medovaha Srotas*** and ***Dhatvagni***, especially ***Mandya***. Hence there is a need for ***Dravya*** which is of ***Usṇa***, ***Rukṣa Gunas*** with ***Lekhan*** & ***Shoshan*** properties to cleanse the ***Medovaha*** Stratos and to increase the ***Dhatvagni***.

So, as per this concept, it is decided to use ***Haritaki*** *processed* in ***Salsaradi Gana Dravya Kwath*** 7 times to sharpen the action of ***Haritaki*** with ***Rasayan*** property. That’s why this research plan has been designed as per ***Rasayan Vidhi*** with ***Aaroh*i-*Avarohi Krama*** of the drug during the trial period.

***Vijaysaradi Kwath*** contains mainly ***Tikta Kashaya Rasa*** and has ***Rukshana*** properties ***Tikta Rasa*** has ***Kledameda- vasa-majja-lasika Shoshana*** properties 5 and is known to be successfully used for the treatment of ***Madhumeha.***

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
50
Inclusion Criteria
  • 1.Patients of either sex in the age group of above 18 years and below 65 years.
  • 2.Classical signs and symptoms of Prameha.
  • 3.Fasting plasma glucose ≤ 200 mg/dl, Post Prandial glucose level ≤ 300 mg/dl.
  • 4.Both insulin-dependent and non-insulin-dependent Type – II Diabetes Mellitus patients will be included.
  • 5.Both newly diagnosed patients on allopathic treatment will be included in this study.
  • 6.The dose of Modern Medicine will be adjusted and tapered during the period of trial as per need.
  • 7.Patients having BMI (Body Mass Index) ≥ 25 and ≤ 35 will be taken for the study.
Exclusion Criteria
  • 1.Patients of either sex in the age group of above 18 years and below 65 years.
  • 2.Classical signs and symptoms of Prameha.
  • 3.Fasting plasma glucose ≤ 200 mg/dl, Post Prandial glucose level ≤ 300 mg/dl.
  • 4.Both insulin-dependent and non-insulin-dependent Type – II Diabetes Mellitus patients will be included.
  • 5.Both newly diagnosed patients on allopathic treatment will be included in this study.
  • 6.The dose of Modern Medicine will be adjusted and tapered during the period of trial as per need.
  • 7.Patients having BMI (Body Mass Index) ≥ 25 and ≤ 35 will be taken for the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in laboratorial parameters as well as signs and symptoms of Sthoola Pramehi (Type – II Diabetes Mellitus).40 Days
Secondary Outcome Measures
NameTimeMethod
To improve quality of life by reducing high blood glucose level.40 days

Trial Locations

Locations (1)

Government Akhandanand Ayurveda College, Ahmedabad

🇮🇳

Ahmadabad, GUJARAT, India

Government Akhandanand Ayurveda College, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Bhagyashreeben Valvi
Principal investigator
6356257310
valvibhagyashri110@gmail.com

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