| CTRI Number |
CTRI/2025/04/084196 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Kadaradi Kashaya For Type 2 Diabetes. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Kadaradi Kashaya In Management Of Madhumeha With Special Reference To 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 Suma C |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Dept of PG Studies in Dravyaguna Sri Sri College Of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura PO OB Chudahalli Banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
9741075787 |
| Fax |
|
| Email |
sumachandrappa1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh CD |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Dept of PG Studies in Dravyaguna Sri Sri College Of Ayurvedic Science and Research 21st KM Kanakapura main road Udayapura PO OB Banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
9986303884 |
| Fax |
|
| Email |
drmaheshcd404@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh CD |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Dept of PG Studies in Dravyaguna Sri Sri College Of Ayurvedic Science and Research 21st KM Kanakapura main road Udayapura PO OB Banglore
Bangalore
KARNATAKA
560082
India |
| Phone |
9986303884 |
| Fax |
|
| Email |
drmaheshcd404@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research 21st KM kanakapura Rd Udayapura PO Banglore 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Suma C |
| Address |
Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura Rd Udayapura PO Banglore 560082 |
| Type of Sponsor |
Other [self] |
|
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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 Suma C |
Sri Sri College of Ayurvedic Science and research Hospital |
Dept of PG Studies in Dravyaguna, Sri Sri College Of Ayurvedic Science and Research Hospital , 21st KM Kanakapura main road, Udayapura PO OB Chudahalli Banglore
Bangalore
KARNATAKA |
09741075787
sumachandrappa1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Asanadi Kashaya, Reference: Ashtanga Hrudayam , Sutrasthana 15th chapter, shloka :19-20, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - Kwatha churna will be given and fresh churna will prepared | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadaradi kashaya, Reference: siddayoga sangraha, Chapter :35, Pramehadikara, shloka no:15, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water ), Additional Information: -kadara, kadhira and puga which will be given in kwatha churna form to patirnts to prepare fresh kashaya. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Freshly diagnosed Subjects with Type 2 Diabetes mellitus having range: 45.
FBS: 126 to 220 mg/dl, PPBS: 200 to 280mg/dl, HbA1c: 5.7 % to 7.5 %.
2.Subjects between age group of 30 to 60 years of either gender.
3.Subjects with BMI more than 25.
4.Subjects who are willing to give written consent for the study. |
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed as Insulin Dependent Diabetes Mellitus (Type 1).
2.Subjects with Gestational diabetes and lactating women.
3.Subjects with complication of Diabetes mellitus.
4.Subjects who are on any intervention for Diabetes Mellitus.
5.Any systemic disorder other than diabetes mellitus which will interfere with present
treatment. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Significant decrease in blood sugar levels assessed based on Fasting blood sugar and Post prandial blood sugar.
|
0th, 15th,30th,45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjects having classical signs and symptoms of Madhumeha like:
Prabhootha mutrata, Avila mutrata ,Kshudha adhikya, Trishnaadhikya Swedaadhikya, Atinidra, Karapada daha, Karapada Suptata ,Daurbalya.
|
0th, 15th,30th,45th day |
|
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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 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="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
|
1.Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose.
2.Hyperglycemia , also called raised blood glucose, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems
3.American Diabetes Association has classified diabetes into type 1, type 2 and Gestational diabetes mellitus
4.As per IDF , Internationally In 2021, 537 million people had Diabetes Mellitus which is expected to rise to 643 million by 2030 and 783 million by 2045.
5.As per WHO, India has the World’s second largest Type 2 epidemic with 77 million suffering from diabetes in 2019 and is expected to rise to over 134 million by 2045
6.Management of type 2 Diabetes mellitus include Diet , Oral Hypoglycaemic therapy and Insulin therapy
7.Conventional medicine has its own limitation, it only help to lower blood sugar level and in a long run it has shown its side effects. They neither able to correct the pathology nor helpful to protect vital organs of the body and to prevent further complications
8.Based on the pathogenesis and clinical presentation Type 2 Diabetes mellitus can be considered as Madhumeha, Santarpanotta janya Vikara with symptoms like polyuria, polydipsia, polyphagia.
9.Medicinal plants such as Guduchi, Amalaki, Haridra , Asana, etc play a significant role in diabetes mellitus. Traditional plants are reported to have significant anti diabetic property with no harmful side effects ,having flavonoids, alkaloid , phenols and tannins that improves the efficacy of pancreatic tissues by increasing the insulin secretion or by decreasing the intestinal absorption of glucose.
10.Acharya Vrundamadva in Siddayoga, has mentioned about Kadaradi Kashaya in Pramehadhikara.
‘Kadarah Khadira Puga Kwatham Kshoudrahrude Peebeth’
11.Asanadi Gana is mentioned in Ashtanga Hrudayam , Sutrasthana. 12.Pterocarpus marsupium Roxb., Pterocarpus santalinus Linn.f., Aquilaria agallocha Roxb. , and many others are listed as Near Threatened, Endangered by the International Union for the Conservation of Nature, on the basis of its decreasing population and declining habitat in its native range. 13.Currently, Indigenous preparation is being used because of unavailability of the ingredients and cost of its preparation. 14.This study focuses on assessing the effect of Kadaradi Kashaya in Madhumeha, where Kadara, Khadira and Puga are abundantly available for the growing population.
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