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
|
|
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
|
|
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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