CTRI/2024/07/070666 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On:
12/07/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Single Arm Study
Public Title of Study
A clinical trial to study the effectiveness of selected Ayurvedic treatment protocol in type 2 Diabetes Mellitus
Scientific Title of Study
Effectiveness of selected Ayurvedic treatment protocol in type 2 Diabetes Mellitus
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Aysha Subinam S
Designation
PG Scholar, Department of Kayachikitsa
Affiliation
Government Ayurveda College, Thiruvananthapuram
Address
Department of Kayachikitsa, OP no.2, Room no: 2, Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala.
Thiruvananthapuram KERALA 695001 India
Phone
8281790413
Fax
Email
drayshasubinam@gmail.com
Details of Contact Person Scientific Query
Name
Dr Aysha Subinam S
Designation
PG Scholar, Department of Kayachikitsa
Affiliation
Government Ayurveda College, Thiruvananthapuram
Address
Department of Kayachikitsa, OP No: 2, Room No: 2, Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala.
KERALA 695001 India
Phone
8281790413
Fax
Email
drayshasubinam@gmail.com
Details of Contact Person Public Query
Name
Dr K Ambika
Designation
Professor and H.O.D, Department of Kayachikitsa
Affiliation
Government Ayurveda College, Thiruvananthapuram
Address
Department of Kayachikitsa, OP No:2, Room No:2, Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala.
Thiruvananthapuram KERALA 695001 India
Phone
9847457084
Fax
Email
ambikachitharanjan@gmail.com
Source of Monetary or Material Support
Government Ayurveda Medical college and Hospital, Thiruvananthapuram, Kerala, India.
Pincode: 695001
Primary Sponsor
Name
Dr Aysha Subinam S
Address
PG Scholar, Department of kayachikitsa, OP No:2, Room No:2, Government Ayurveda Medical College and Hospital, Thiruvananthapuram, Kerala, India.
Pincode: 695001
Type of Sponsor
Other [Self]
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 Aysha Subinam S
Government Ayurveda Medical College and Hospital,Thiruvananthapuram
Department of Kayachikitsa , OP No 2, Room No :2 ,Government Ayurveda Medical College and Hospital, Thiruvananthapura, Kerala, India.
Pincode -695001 Thiruvananthapuram KERALA
(Procedure Reference: Caraka Samhitha, Procedure details: Done along with ushma sweda for 3 days) (1) Medicine Name: Nisoseeradi thailam, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
4
Intervention Arm
Procedure
-
virecana-karma, विरेचन-करà¥à¤®
(Procedure Reference: Caraka Samhitha, Procedure details: In the morning, after kapha time has lapsed, virechana drug is given. Quantity of medicine should be determining the nature of his koshta.) (1) Medicine Name: Nimbamrthadi eranda thailam, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 1 Days
Inclusion Criteria
Age From
30.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1.Male and female participants of age group between 30-60 years
2.Participants with history of Type 2 Diabetes Mellitus
3.Participants with FBS value from 150-250mg/dl and PPBS value from 200-350mg/dl
4.Participants with HbA1C ≥ 6.5% & ≤ 9%
ExclusionCriteria
Details
1.Known cases of any serious systemic illness under medication
2.Pregnant and lactating women
3.Participants on steroids/oral contraceptive pills/oestrogen replacement therapies.
4.Undergone GI Surgeries/Malignancies
5.Type 1 DM/on insulin therapy
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Changes in the score of variables FBS, PPBS, HbA1C.
0th day and 91st day
Secondary Outcome
Outcome
TimePoints
Improvement in Quality of life- will be assessed by - QOLID
0th day & 91st day
Target Sample Size
Total Sample Size="24" Sample Size from India="24" 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/ Phase 3
Date of First Enrollment (India)
24/07/2024
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Diabetes Mellitus(DM) also called as Diabetes, refers to a group of metabolic diseases characterized by abnormal glucose homeostasis resulting in elevated blood sugar. It is considered as one of the largest global emergencies of this century. the most common type is type 2 DM, usually seen in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. According to International Diabetes federation (IDF), diabetes affects an estimated 537 million people worldwide. It is projected that, by 2030, 643 million people will have diabetes worldwide, increasing to 783 million by 2045. The burden of Type 2 DM in India is massive, and with 77 million people, the country ranks second for having the highest number of Type 2 DM patients in the world, following china. Based on a study conducted by ICMR, the prevalence of diabetes in India is 11.4%. Kerala is at third position after Goa and Puducherry with prevalence rate of 23.6%. Prameha is a well known clinical syndrome since time immemorial. The word Prameha was first mentioned in Caraka samhitha, which is akin to Diabetes. It is a kapha pradhana tridoshajanya vyadhi in which medas is the pradhana dooshya. It is characterised by Prabhoota avila mootrata which means frequent and turbid urination. Based on the predominance of dosas, 20 types of prameha are mentioned in all classics. Among them, the most important disorder is madhumeha. A subtype of madhumeha i.e., avarajanya madhumeha ma be correlated to Type 2 Diabetes mellitus. The objective of this study is to determine the effectiveness of selected Ayurvedic treatment protocol in Type 2 Diabetes Mellitus. In this study, the participants will be selected and assigned under a single group. The study is of interventional type. Both male and female participants of age group 30-60 years with FBS level from 150-250mg/dL and PPBS level from 200-350mg/dL, attending the OPD and IPD of Government Ayurveda College, thiruvananthapuram will be selected for the study. the required laboratory investigations will be done before and after the study period. The collected data will be subjected to statistical analysis using appropriate statistical techniques. Results will be drawn, summarized and conclusions will be made.