CTRI Number |
CTRI/2023/08/056755 [Registered on: 22/08/2023] Trial Registered Prospectively |
Last Modified On: |
18/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A combined study 0f combined effectiveness, Lodhradi Kashaya And Navaka Guggulu in patients with Madumeha (Type 2 Diabetes Mellitus) |
Scientific Title of Study
|
An open label, single arm clinical study on the combined effectiveness of Lodhradi Kashaya And Navaka Guggulu In Madumeha (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 Shreya M Bangre |
Designation |
PG Scholor |
Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,Hassan
Hassan-573201, Karnataka, India Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,Hassan
Hassan-573201, Karnataka, India Hassan KARNATAKA 573201 India |
Phone |
7204780880 |
Fax |
|
Email |
anumyd1993@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR Shreya M Bangre |
Designation |
PG Scholor |
Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,Hassan
Hassan-573201, Karnataka, India Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,Hassan
Hassan-573201, Karnataka, India Hassan KARNATAKA 573201 India |
Phone |
7204780880 |
Fax |
|
Email |
anumyd1993@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR TOTAD MUTTAPPA |
Designation |
Associate Profeesor |
Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,
Hassan-573201, Karnataka, India Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,
Hassan-573201, Karnataka, India Hassan KARNATAKA 573201 India |
Phone |
9886924949 |
Fax |
|
Email |
totadmv225@gmail.com |
|
Source of Monetary or Material Support
|
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
|
Primary Sponsor
|
Name |
Sri Dharmasthala Manjunatheswara College of Ayurveda and |
Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital, BM Road, Thanniruhalla,
Hassan-573201, Karnataka, India |
Type of Sponsor |
Private medical college |
|
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 SHREYA M BANGRE |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital |
Sri Dharmasthala Manjunatheswara College of Ayurveda and
Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India Hassan KARNATAKA |
7204780880 - anumyd1993@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LODHRADI KASHAYA, Reference: BASAVARAJEEYAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WARM WATER), Additional Information: 15-20 MINS BEFORE FOOD | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NAVAKA GUGGULU, Reference: CAHKRADATTA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Subjects above 30 years up to 70 years of either gender
suffering from Type 2 Diabetes
Mellitus under control will be taken.
2.Fasting blood sugar ≥ 126 mg/dL.
3.Post prandial blood sugar (PPBS) level ≥180 mg/dL.
4.Those patients willing to participate in the study and
who are ready to sign the informed
|
|
ExclusionCriteria |
Details |
1.Subjects of Type 2 Diabetes Mellitus on insulin
2.Subjects of Type 2 Diabetes Mellitus with HbA1c
>10%, FBS >250 mg/dl, PPBS >350mg/dl
3.Subjects with known case of cardiac illness,
impaired kidney and liver function
4.Pregnant women and lactating mother
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
polyurea
polydipsia
polyphagaia
karapada daha
karapada suptata
angasaada |
30 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Fasting blood glucose & Post prandial blood glucose- Before & after treatment (1st day & 31st day) |
30 days |
|
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/ Phase 3 |
Date of First Enrollment (India)
|
31/08/2023 |
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 Yet Recruiting |
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
|
In this present generation the sedentary life style, lack of exercise, stress, life style modifications, change in dietary habits, urbanization precipitate the disease of Santarpanjanya vyadhis like as Prameha 1. It told as one of the astamahaagadas 2, Madhumeha is a Vataja Prameha 3 .Prameha is characterized by Prabhutha mutratva and Avila mutratva 4 The clinical feature like Madhura asyata , karapadadaha, suptata, mukha talu kanthashosha, pipasa-adhikya, alasya, tandra 5 can be correlated to the features of Type 2 Diabetes Mellitus.Diabetes Mellitus Type 2 and its complications pose a major threat to public health resource throughout the world. In today’s era, Type 2 Diabetes Mellitus has gained gigantic disgrace in recent times as it is fast becoming the world’s largest silent killer. In 2021, Approximately 537 million adults (20-79 years) are living with Type 2 Diabetes Mellitus.The total number of people living with diabetes Type 2 is projected to rise to 643 million by 2030 and 783 million by 20456. It has become utmost importance to find ways to combat this disease. Adults with Type 2 Diabetes Mellitus have a two-threefold increased risk of heart attacks and strokes. Diabetes is the cause of 2.6% of global blindness and it’s also a leading causes of kidney failure 7. With an increasing incidence worldwide and due to chronic complications, there is need for effective management of Type 2 Diabetes mellitus. Ingredients of Lodhradi Kashaya possess tikta kashaya rasa, laghu guna, katu vipaka,pramehagna karma and Navaka guggulu possess katu tikta rasa, laghu ,rooksha guna,kapha vatahara, medohara ,amapachana karma. As madumeha is santarparnajanya vyadhi. Kapha and vata is main dosha and meda is main dushya involved in the manifestation of vyadhi. These formulations may help to act against it. The ingredients of both formulations are safe and easily available. This study is intended to evaluate the effectiveness of this combination in madhumeha . |