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CTRI Number  CTRI/2025/03/082198 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effectiveness of sarodaka, kushodaka and madhudaka in treating Diabetes 
Scientific Title of Study   A comparative study to evaluate the efficacy of Sarodaka, Kushodaka and Madhudaka as pathya in the management of Prameha vis-a-vis 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 Ankitha U K  
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital,Mysuru 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9380033778  
Fax    
Email  ukankitha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Venkatakrishna K V 
Designation  Professor 
Affiliation  Government Ayurveda Medical College and Hospital,Mysuru 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9448572614  
Fax    
Email  srisadguru@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankitha U K  
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital,Mysore 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9380033778  
Fax    
Email  ukankitha@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital, Vishveshvarayya circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001 
 
Primary Sponsor  
Name  Dr Ankitha U K  
Address  Government Ayurveda Medical College and Hospital, Mysuru 
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 Ankitha U K  Government Ayurveda Medical College and Hospital  Room 12,Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka
Mysore
KARNATAKA 
9380033778

ukankitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda Medical College and Hospital Mysuru  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: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Madhudaka, Reference: Charaka chikitsa sthana 6/46, Route: Oral, Dosage Form: Phanta, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Sarodaka, Reference: Charaka chikitsa sthana 6/46, Route: Oral, Dosage Form: Phanta, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Kushodaka, Reference: Charaka chikitsa sthana 6/46, Route: Oral, Dosage Form: Phanta, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Subjects of age group between 25 to 55 years fulfilling the diagnostic criteria will be selected for the study
2. Diagnosed case of Diabetes within 5 years of onset  
 
ExclusionCriteria 
Details  Newly diagnosed case of Diabetes who are not under any medication
Diagnosed case of Diabetic neuropathy, nephropathy and retinopathy
Type 1 Diabetes Mellitus
Subjects under insulin therapy
Pregnant and lactating women
known cases of chronic systemic illness
Diabetic subjects having
Fasting Plasma Flucose more than 200mg/dL
Plasma Glucose in random sample or 2 hours after a 75 gram glucose load more than 350 mg/dL
HbA1c more than 10% 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Sarodaka as pathya in Prameha
Effect of Kushodaka as pathya in Prameha
Effect of Madhudaka as pathya in Prameha 
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Sarodaka, Kushodaka and Madhudaka in Prameha.  12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   30/03/2025 
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  

Prameha is defined as Prakarshena Prabhutam Prachuram varam varam va mehati mutratyagam karoti iti pramehah. It is a sleshmapradhana tridoshaja vyadhi which is caused due to santarpana. It is one of the ashta mahagada. Apathya is one of the main etiological factors of prameha. Anna pana and kriya vikruthi are responsible for the causation of the disease. The samanya lakshanas of prameha include prabhuta avila mutrata associated with other lakshanas like gurugatrata alasya  hastapadatala daha kshuth pipasa adhikya sada etc. Further progression of prameha affects all the dasha dushyas including medas and shareeraja kleda and leads to upadrava. Therefore, considering apathya ahara and vihara as major causes for the disease manifestation and as Nidana parivarjana is one of the first lines of treatment told in Ayurveda, avoiding the same and indulging in pathya anna pana and vihara plays an important role in chikitsa.

The term Diabetes mellitus refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Type 2 Diabetes Mellitus is a heterogeneous group of disorders characterized by variable degrees of insulin resistance, impaired insulin secretion, and increased hepatic glucose production.

International Diabetes Atlas (IDF) (2021) reports that 10.5% of the adult population (20-79 yrs.) has diabetes. As per the Indian Council of Medical Research- India Diabetes study published in 2023 the prevalence of Diabetes is 10.1 crore. India is home to 77 million Diabetes which is the second highest in the world.

 The American Diabetes Association uses the term Lifestyle Management to refer to aspects of Diabetic care Diabetes self-management education (DSME) and Diabetes self-management support (DSMS) Nutrition therapy and psychosocial care Pharmacological approaches include oral glucose-lowering agents, Insulin, and other agents that improve glucose control.

Even with the advancement of various drug therapies, still, the prevalence of the disease is increasing day by day.

Ahara is referred to as mahabheshaja. Since Prameha is considered to be a Yapya vyadhi pathya ahara sevana plays an important role in its management. Among various pathyas described Sarodaka Kushodaka and Madhudaka are explained in prameha chikitsa.  They have properties like tikta, kashaya rasa kaphapittahara medoghna and has a special reference in prameha chikitsa. Therefore this study aims to evaluate the effect of these as pathya in the management of Prameha.


 
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