| CTRI Number |
CTRI/2022/07/043661 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| 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 clinical study to know efficacy of formulations, Saptachakra churna and Amalaki churna in Madhumeha management w.s.r Type-2 DM |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study to Evaluate Efficacy of Saptachakra Churna (Salacia Reticulata) in Madhumeha w.s.r Type-2 DM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Javeed Chougala |
| Designation |
P.G. Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College and Hospital Kayachikitsa OPD, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8951885120 |
| Fax |
|
| Email |
javeedchougala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
P.G Scholar MD (Ayurveda) |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College and Hospital Kayachikitsa OPD and Department, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
drsurpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Javeed Chougala |
| Designation |
P.G. Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College and Hospital Kayachikitsa OPD and Department, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8951885120 |
| Fax |
|
| Email |
javeedchougala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr Javeed Chougala |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri.
Dakashina Kannada
KARNATAKA
574227
India |
| Type of Sponsor |
Private medical college |
|
|
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 Javeed Chougala |
Alvas Ayurveda Hospital |
Alvas Ayurveda Medical College and Hospital Kayachikitsa OPD and Department, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA |
8951885120
javeedchougala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodbidri, India |
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: Madhumeha, (2) 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: Amalaki, Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Saptachakra, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with FBS range Between 126 - 250 mg/dL and PPBS range between 200 - 350 mg/dL Type-2 Diabetes Mellitus will be selected for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with High blood glucose levels FBS > 250mg/dL and PPBS > 350 mg/dL
2. Patients with complications like DKA, HHS, Diabetic Gangrene and Carbuncles
3. Gestational Diabetes, Patients on Insulin Type 2 Diabetes Mellitus.
4. Diabetes with other Endocrine Disorders are excluded from the study
5. Patients suffering from other Systemic Diseases which may interfere with study will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of the treatment will be done based on detailed case proforma with objective parameters FBS and PPBS |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of the treatment will be done based on detailed case proforma with subjective parameters such Prabhuta avila mutra, Ati Kshudha, Ati Trusha, Ati Sveda |
30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
04/07/2022 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised, single blind, parallel group, actively controlled clinical study with comparative standard drug - Amalaki Churna and Trial drug - Saptachakra Churna with the dosage 5gm churna with ushnodaka before food BID. This study is conducting in Madhumeha patients belongs to age group between 20yrs - 70yrs who gives written and verbal consent for undergoing clinical study. Study will be conducting in Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri. Intervention of the study is 30 days with day zero, day 11, day 21 and day 31 assessment. |