| CTRI Number |
CTRI/2024/07/070248 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on human participants to evaluate the role of Avipattikara churna (an Ayurveda medicine) in managing Diabetes Mellitus. |
|
Scientific Title of Study
|
A Randomized open labelled controlled clinical study to evaluate the efficacy of Avipattikara churna in prameha 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 Vandita M |
| Designation |
PG Scholor . |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
7795081814 |
| Fax |
|
| Email |
mvandita6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
8147891325 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
8147891325 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research 21st KM,Kanakapura Road, Udayapura Post,
Bengaluru,Karnataka, 560082,India. |
|
|
Primary Sponsor
|
| Name |
Dr. Vandita M |
| Address |
OPD No. 5 Dept of PG Studies in Kayachitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore |
| 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 Vandita |
Sri Sri College of Ayurvedic Science and Research Hospital |
OPD No 5,Dept.of Kayachikitsa.
Bangalore
KARNATAKA |
7795081814
mvandita6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Avipattikara Churna , Reference: Bhaishajya ratnavali Amlapitta Adhikara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishaamalaki Churna, Reference: Ashtanga hridaya Chikitsa sthana 12th chapter., Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with Diabetes Mellitus having HbA1C within range of 6.5% to 8%.
2.Subjects between the age group of 30 to 60 years irrespective of gender.
3.Subjects willing to participate with written informed consent, which is conveyed in the language, which the subject can understand.
|
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with Type1 Diabetes Mellitus.
2.Subjects who are on any intervention for Diabetes Mellitus.
3.Pregnant and Lactating women.
4.Subjects with diseases which may interfere with disease or course of treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in Blood Sugar levels assessed based on Fasting Blood Sugar and Post Prandial Blood Sugar. |
before intervention - 0th day
After intervention - 30th day
Follow up - 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the quality of life.
Generation of in depth analysed data on the
different aspect of the disease.
Generation of data on possible unexpected drug
reaction. |
Before intervention - 0th day
After intervention -30th day
After drugfree Follow up - 45th day . |
|
|
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)
|
20/07/2024 |
| 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="0"
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 a metabolic non communicable disease, one of the most serious health challenges worldwide adding to the economical burden. It is characterized by chronic hyperglycemia resulting from reduced insulin secretion, decreased glucose utilization and increased glucose production. American diabetes association has classified diabetes mellitus into type-1, type-2 and Gestational diabetes mellitus. As per IDF. In 2021 537 million people had Diabetes Mellitus which is expected to rise to 643 million by 2030 and 783 million by 2045. Men having slightly higher rates than women. According to IDF, incidence of Diabetes Mellitus in India was 9.6% in 2021 which is expected to rise to 10.9% by 2045.
According to WHO in 2019, diabetes mellitus accounted for 1.6 million deaths becoming the 9th leading cause of death. Based on the presentation and pathogenesis of type 2 diabetes mellitus, the disease can be understood as Prameha, a Santarpanottha vikara, characterized with excessive urination (both in frequency and quantity) and change in appearance. According to contemporary science along with oral hypoglycemic agents, diet and lifestyle modification is stressed upon. Currently, various anti diabetic drugs in contemporary medicine are used for controlling diabetes which is lifelong requirement in general. But their long applications cause adverse drug reactions including gastro intestinal disturbances, renal and hepatic impairment. In Ayurveda, various drugs are used to treat Diabetes Mellitus.
As Ayurvedic medications show a better management in improving symptoms, there is a need to search a effective medication for diabetes mellitus over synthetic /chemical preparations. Avipattikara churna mentioned in Bhaishajya ratnavali in the context of Amlapittadhikara is attributed to be having property for management of vimshathi prameha. Hence, considering the above background, it is thought worthy to evaluate the efficacy of Avipattikara churna in the management of prameha with special reference to Type 2 Diabetes Mellitus. Nishaamalaki churna is a proven and commonly used drug for management of Diabetes Mellitus considering that it is taken as a control drug for the present study. |