| CTRI Number |
CTRI/2025/02/080528 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Synergistic activity of Honey as Anti-Hyperglycemic when given with Triphala Kashaya in Pre-Diabetes. |
|
Scientific Title of Study
|
EVALUATION OF YOGAVAHITVA OF MADHU WITH SPECIAL REFERENCE TO SAMYOGA ON ANTI- HYPERGLYCAEMIC ACTIVITY OF TRIPHALA IN PRE-DIABETES – A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY |
| 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 GRAMA SRIRANGARAJU SAHANA |
| Designation |
POST-GRADUATE SCHOLOR |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU, KARNATAKA |
| Address |
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU. #41/E, LALITHADRIPIURA ROAD, ALANAHALLI, MYSURU, KARNATAKA
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
Mysore
KARNATAKA
570028
India |
| Phone |
9972901962 |
| Fax |
|
| Email |
gramasrisahana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Pai |
| Designation |
Professor and HOD |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU, KARNATAKA |
| Address |
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU. #41/E, LALITHADRIPIURA ROAD, ALANAHALLI, MYSURU, KARNATAKA
Mysore
KARNATAKA
570028
India |
| Phone |
8073822295 |
| Fax |
|
| Email |
satishayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GRAMA SRIRANGARAJU SAHANA |
| Designation |
POST-GRADUATE SCHOLOR |
| Affiliation |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU, KARNATAKA |
| Address |
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU. #41/E, LALITHADRIPIURA ROAD, ALANAHALLI, MYSURU, KARNATAKA
Department of Dravyaguna Vigyana , JSS Ayurveda Hospital, OPD: 7
Mysore
KARNATAKA
570028
India |
| Phone |
9972901962 |
| Fax |
|
| Email |
gramasrisahana@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical college and Hospital,
#41/E LAlithadripura Road, Alanahalli, Mysuru -570028
Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
DR GRAMA SRIRANGARAJU SAHANA |
| Address |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU. #41/E, LALITHADRIPIURA ROAD, ALANAHALLI, MYSURU, KARNATAKA
Mysore, Karnataka |
| Type of Sponsor |
Other [Individual] |
|
|
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 GRAMA SRIRANGARAJU SAHANA |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MYSURU, KARNATAKA |
Department of Dravyaguna Vigyana, OPD No: 7
#41/E, Lalithadripura Road
Mysore -570028, Karnataka
Mysore
KARNATAKA |
9972901962
gramasrisahana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MUSURU |
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: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Diet and Exercise pattern, Ritucarya: Consumption of seasonal vegetables and fruits along with following the ritu anukula pathya and apathya will be decided on an individual subject basis., Acara Rasayana:, Other:Exercise - 3 to 4 times a week.
Diet- 3 months duration, Pathya/Apathya:yes, Pathya:Ragi Peya, Upma, Mugdha Yusha, Wheat dosa, Mugdha khichdi, Ragi ball, Chapati with good quantity of vegetable serving, small portion of rice with Sambar or a Vegetable serving on a daily basis. Intake of Buttermilk, Ashgaurd juice, Ragi ambli., Apathya:Avoid Madhura,Katu and tikta Ahara | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Kashaya , Reference: Kaiyadeva Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: -100 ml per day in divided doses which consists of approximate 15.3g extract if given in a ghana vati dose in case of practical difficulty. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhu, Reference: Chakradatta Prameha Roga Adhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Triphala Kashaya), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Pre-Diabetes irrespective of gender and Socio-Economic status will be selected.
Subjects of age group 25-60 years will be selected
Fasting Blood Sugar level: 100-125mg/dl
Post Prandial Blood Sugar level: 140-199mg/dl
HbA1c: 5.7%-6.4%
Patients with pre-obese category and class 1 obesity
Patients fulfilling the Diagnostic criteria with or without associated complaints of
Polyuria, Polydipsia, Polyphagia, Tiredness and Weight parameter. |
|
| ExclusionCriteria |
| Details |
Any other systemic disorder which requires emergency management.
Long term Diabetics with severe complications such as Diabetic neuropathy,
Diabetic Nephropathy, Retinopathy, Ischemic Heart Disease, Gestational Diabetes,
Diabetes Mellitus Type 1 and complaints related to mobility.
Secondary Diabetics, Bronze Diabetes and Stage 2 hypertensives.
Pregnant and Lactating Women.
Patients will Liver cirrhosis, Sexually Transmitted Disorders, HIV, Pancreatitis,
Hepatitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate the Anti-Hyperglycaemic effect of Triphala in Pre-Diabetes.
To Evaluate the Yogavahitwa of Madhu with special reference to Samyoga on
Anti-Hyperglycaemic activity of Triphala in Pre-Diabetes.
To compare the Anti-Hyperglycaemic effect of Triphala and Madhu mishrita
Triphala with Standard Care [Diet and Exercise] |
6-12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fasting Blood Sugar level: 100-125mg/dl
Post Prandial Blood Sugar level: 140-199mg/dl
HbA1c: 5.7%-6.4%
Patients fulfilling the Diagnostic criteria with or without associated complaints of
Polyuria, Polydipsia, Polyphagia, Tiredness & Weight parameter |
6 to 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Months="3"
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 is one of the largest global public health concerns, imposing a heavy
global burden on public health as well as Socio-economic development. Diabetes Atlas
2021 reports that 10.5% of the adult population ranging from 20-29 years have Diabetes. By
2045, IDF projections show that 1 in 8 adults, will be living with Diabetes, an increase of
45%. In India, there are estimated 77 million people above the age of 18 years and nearly
25 million are prediabetics with more than 50% of people are unaware of their diabetic
status. Hyperglycaemia-induced oxidative stress is central to the development of diabetes.
Studies have shown that polyphenols could reduce and reverse oxidative stress associated
hyperglycemia. Phenolics due to their poor bioavailability often fail in getting absorbed
properly from gut and hence need bio-availability enhancers, which could bring enhanced
effects.
Honey has lower glycemic index and decreases the fasting blood glucose. Honey
protects against metabolic syndrome by exerting antidiabetic activity. It keeps the gut
healthy as it increases the bioavailability of Phenolics which are digested by the Gut
microbe. The active principles of Triphala are predominantly hydrolysable tannins. Their antioxidant
activity of Triphala correlates with their Antidiabetic property. Adults treated with
Intensive Lifestyle Treatment have chances of achieving remission of diabetes. |