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CTRI Number  CTRI/2021/06/033927 [Registered on: 01/06/2021] Trial Registered Prospectively
Last Modified On: 05/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Tulsi and Krishna Tulsi in Prameha 
Scientific Title of Study   Randomised comparative clinical trial to evaluate the efficacy of Tulsi and Krishna Tulsi(Ocimum Sanctum Linn.) in Prameha w..s.r. to Pre-diabetes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti 
Designation  PG Scholar Dravyaguna deptt NIA Jaipur 
Affiliation  National Institute Of Ayurveda 
Address  National Institute of Ayurveda Jorawer singh gate,Amer Road Jaipur RAJASTHAN 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9996221023  
Fax    
Email  preetinandal5401@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof A Ramamurthy 
Designation  Professor 
Affiliation  National Institute Of Ayurveda 
Address  National Institute of Ayurveda Jorawer singh gate,Amer Road Jaipur RAJASTHAN 302002
National Institute of Ayurveda Jorawer singh gate,Amer Road Jaipur RAJASTHAN 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9314513659  
Fax    
Email  armurthy_2005@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti 
Designation  PG Scholar Dravyaguna deptt NIA Jaipur 
Affiliation  National Institute Of Ayurveda 
Address  National Institute of Ayurveda Jorawer singh gate,Amer Road Jaipur RAJASTHAN 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9996221023  
Fax    
Email  preetinandal5401@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda,jorawar singh Gate,Amer Road,Jaipur,Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar singh Gate,Amer Road,Jaipur,Rajasthan 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti  National Institute Of Ayurveda  OPD No.19 Department Of Dravyaguna Vigyan,Jorawer singh gate,Amer Road,JaipurRajasthan
Jaipur
RAJASTHAN 
9996221023

preetinandal5401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: pramehah,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ksishna Tulsi Capsule  Group B-15 patients of prameha will be selected and 3 krishna tulsi capsule will be given before meal orally for 1 month 
Intervention  Tulsi Capsule   Group A-15 patients of prameha will be selected and 3 tulsi capsules per day will be given orally before meal twice a day for 1 month 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 20-60 years.
2. Patients with fasting blood sugar in the range
of 100-125mg/dl,post prandial blood sugar in
range of 140-199mg/dl 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in blood glucose level.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in triglyceride,HDL,LDL,Cholestrol level and BMI.  4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 


 
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