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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  
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 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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
2Intervention ArmDrugClassical(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 .

 
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