| CTRI Number |
CTRI/2024/03/063911 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to study the effects of two drugs, Mutravirechaniya Mahakashaya and Aamlaki Swaras in Patients with Chronic Renal Failure |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of Mutravirechaniya Mahakashaya along with Aamlaki Swaras in the management of chronic renal failure |
| Trial Acronym |
MMAAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satya Deo Pandey |
| Designation |
Professor and Head of Department Kayachikitsa |
| Affiliation |
Desh Bhagat Ayurvedic University, Mandi Gobindgarh |
| Address |
Director of clinical research,
HOD, Department of Kayachikitsa, Desh Bhagat University, Mandi Gobindgarh Punjab
Desh Bhagat Ayurvedic college and hospital
department of Kayachikitsa, Amloh Road, Mandi Gobindgarh Punjab
Fatehgarh Sahib
PUNJAB
141411
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
sdkayachikitsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya Deo Pandey |
| Designation |
Professor and HOD Kayachikitsa |
| Affiliation |
Desh Bhagat Ayurvedic University, Mandi Gobindgarh |
| Address |
Director of clinical Research,
Head of Kayachikitsa Department, Desh Bhagat University, Mandi Gobindgarh, Punjab.
Desh Bhagat University, Amloh Road, Mandi Gobindgarh Punjab
Fatehgarh Sahib
PUNJAB
141411
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
sdkayachikitsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NISHU |
| Designation |
Associate Professor |
| Affiliation |
Dayanand Ayurvedic Hospital Jalandhar |
| Address |
Dayanand Ayurvedic Hospital
Kayachikitsa OPD
Room No 12
Jalandhar Punjab
144008
Not Applicable
Jalandhar
PUNJAB
144001
India |
| Phone |
8360083394 |
| Fax |
|
| Email |
nishu.raina2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hans Raj Marg, G.T Road Jalandhar Punjab-144008 |
|
|
Primary Sponsor
|
| Name |
Dr Nishu Raina |
| Address |
Kayachikitsa Department
Desh Bhagat Ayurvedic College, Amloh Mandi Gobindgarh Punjab |
| Type of Sponsor |
Other [self(Dr. Nishu Raina, PhD Scholar)] |
|
|
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 Nishu |
Dayanand Ayurvedic college jalandhar |
Kayachikista Department
Room No 12
Adjoining reception counter of the hospital.
Jalandhar
PUNJAB |
8360083394
nishu.raina2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Desh Bhagat Ayurvedic college institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: Jirna or Prvrddha Vrkkadosa, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mutravirechaniya Mahakashaya, Reference: Charak samhita sutra sthana 4/35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: In this study, there is comparison between the two groups A and B, in which Group A Patients are given both the drugs that are Mutravirechaniya Mahakashaya and Aamlaki swaras, while in Group B, Patients are given only Mutravirechaniya Mahakashaya(2) Medicine Name: Aamlaki swaras, Reference: Sushrutra Samhita Uttar Tantra 58/40, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: In t | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mutravirechaniya Mahakashaya, Reference: Charak samhita sutra sthana 4/35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: In this study, there is comparison between the two groups A and B, in which Group A Patients are given both the drugs that are Mutravirechaniya Mahakashaya and Aamlaki swaras, while in Group B, Patients are given only Mutravirechaniya Mahakashaya(2) Medicine Name: Aamlaki swaras, Reference: Sushrutra Samhita Uttar Tantra 58/40, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: In t |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
In this study, Patients willing for trial and are diagnosed cases of Chronic Renal failure of stage 2 on the basis of sign and symptoms of Ayurveda and objective parameters are included.
|
|
| ExclusionCriteria |
| Details |
Patient of age below 15 years and above 70 years, any stage that requires dialysis, Uncontrolled Diabetes/Hypertension, Pregnancy, Malignancy and HIV-Associated Nephropathy were excluded from this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessed by change in signs and symptoms of patients of Chronic Renal failure.
|
40 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by change in objective parameters. |
40 Days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
16/03/2024 |
| 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="0"
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
|
Our study is to evaluate the clinical efficiacy of mtravirechanay mahakashaya along with aamlaki swaras in the management of chronic renal failure..Total 46 Subjects will be selected for clinical study. The selected subjects for the study will be divided into two groups, group A and Group B, each group consists of equal number of Patients. Convenient sampling Techniques will be used. It is basically a Controlled study with Total number of two Trial Groups. Patients that will attend the opd of kayachikitsa and as per the guidelines of inclusion and exclusion criteria will be recruited and medicinal efficiacy will be evaluated in 2 to 6 months time duration. patient are called for follow up after every 20 days( two follow ups) This study is open label clinical and comparative in nature |