Effectiveness of Tulsi and Krishna Tulsi in Prameha

Phase 2

Not yet recruiting

• Conditions: Abnormal glucose. Ayurveda Condition: pramehah,

• Registration Number: CTRI/2021/06/033927
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

The predominant cause of global morbidity and mortality is lifestyle related chronic disease, many of which can be addressed through Ayurveda with its focus on healthy lifestyle practices. Metabolic stress due to poor diet ,low physical activity and psychological stress is a prominent feature of modern lifestyle. Metabolic syndrome also known as Pre-diabetes, is estimated to affect as much as one -third of modern population.

Pre-diabetes is a condition defined as having blood glucose levels above normal but below the defined threshold of diabetes. Prameha is mentioned in our ancient Ayurvedic texts as a syndrome that comprises a number of diseases with various physical and chemical changes in urine. The Visesha lakshana of the disease is described as Prabhootavilamootratha which means copious flow of cloudy or turbid urine frequently. It is mentioned if Prameha is not treated properly in due course of time, it may transform into Madhumeha which is a subtype of Vatika Prameha that occurs at the terminal stage of the disease.

According to the etiological factors, clinical features and pathogenesis Madhumeha can be correlated with Diabetes Mellitus (DM) which is the most common endocrine and metabolic disorder marked by high level of blood glucose resulting from defects in insulin secretion, glucose production and utilization. As per WHO, DM is defined as a heterogeneous metabolic disorder characterised by common feature of chronic hyperglycemia with disturbance of carbohydrate fat and protein metabolism[2].Pre-diabetes includes Impaired Fasting Glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type II diabetes, as it is identified and reversed.

[3]

Tulsi is a aromatic shrub in the basil family lamiaceae that is thought to have originatedinnorth central India and now grows native throughout the eastern world tropics.

[3]

There are large number of drugs in ayurvedic texts advised for the management of Prameha. In present study, Tulsi & Krishna Tulsi (Ocimum sanctum Linn.) have been selected in patients of Prameha.

Antidiabetic activity of Ocimum sanctum Linn. has been proven by many pharmacological researches of Glucose metabolism and thereby it had been proven its Glycemic control. The present research work aims at the clinical significance of Tulsi and Krishna Tulsi in the patients of prameha wsr to Prediabetes.

Aim:

∙ To assess the clinical efficacy of Tulsi and Krishna Tulsi in the patients of prameha (Prediabetes).

Objectives:

∙To evaluate the pharmacognostical and phytochemicals properties of Tulsi (Ocimum sanctum Linn.).

∙To explore an Ayurvedic oral hypoglycemic formulation, this is safe, economical and easily accessible to patients and also devoid of side effects.

CRITERIA FOR ASSESSMENT

The effect of trial drug will be assessed on following parameters –

a. Pramehapurvarupa

1. Alasya (lethargy)

2. Angagandha (Bad odour)

3. Mukha-Talu-Kantha Shosha (Dryness in mouth

4. Kesha Nakh Ati Vridhi (Growth of hairs & nails)

5. Shitapriyatwam (Liking to cold)

6. Karapadadaha (Burning sensation of palms and feet)

7. Karapadasuptata (Numbness of palms and feet)

8. Madhurasyata (Sweetness in mouth)

9. Nidra (Sleep)

10. Pipasa (Polydipisia)

b. Hamilton Anxiety Rating Scale (HAM-A)

c. Laboratory investigations

1. Fasting Blood Sugar (FBS)

2. Post Prandial Blood Sugar (PPBS)

3. Urine - Routine and Microscopic examination.

4. Lipid Profile

The results obtained from In-vitro study, Clinical & Laboratory assessment on subjective& objective parameter will be calculated and statistically analysed.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-05
• Study Start: 2021-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients in the age group of 20-60 years.
• Patients with fasting blood sugar in the range of 100-125mg/dl,post prandial blood sugar in range of 140-199mg/dl.

Exclusion Criteria

• 1.Patients having type 1 DM.
• 2.Patients having any serious illness like coronary artery disease, malignancy, kidney disease etc.
• 3.Patient whose FBS>125mg/dl or PPBS>200mg/dl 4.Pregnant and Lactating mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in blood glucose level.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in triglyceride,HDL,LDL,Cholestrol level and BMI.	4 weeks

Trial Locations

Locations (1)

National Institute Of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute Of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Preeti

Principal investigator

9996221023

preetinandal5401@gmail.com