| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: - | | 3 | Intervention Arm | Drug | Classical | | (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. |