| CTRI Number |
CTRI/2024/08/072972 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO FIND THE EFFECT OF TRIPHALADI KASHAYAM WITH INCREASED MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIPHALADI KASHAYAM ON MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS (MADHUMEHA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Payal Durge |
| Designation |
Postgraduate Scholar (Dept. of Kayachikitsa) |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa
Room no 17
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Poonamallee
Chennai
Thiruvallur TAMIL NADU 600123 India |
| Phone |
9284072554 |
| Fax |
|
| Email |
payaldurge001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vipin S G |
| Designation |
Associate Professor (Dept. of Kayachikitsa),SJSACH ,Chennai |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa
Room no 17
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Poonamallee
Chennai Thiruvallur TAMIL NADU 600123 India |
| Phone |
8547626217 |
| Fax |
|
| Email |
drvipinsg@sjsach.org.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vipin S G |
| Designation |
Associate Professor (Dept. of Kayachikitsa),SJSACH ,Chennai |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa
Room no 17
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Poonamallee
Chennai
TAMIL NADU 600123 India |
| Phone |
8547626217 |
| Fax |
|
| Email |
drvipinsg@sjsach.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai Thiruvallur
TamilNadu
India 600123 |
|
|
Primary Sponsor
|
| Name |
Payal Durge |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Poonamallee
Chennai |
| 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 Payal Durge |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Department of Kayachikitsa
Room no 17
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Poonamallee
Chennai Thiruvallur TAMIL NADU |
9284072554
payaldurge001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Jayendra Saraswathi Ayurveda College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi kashayam, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aragwadadhi kashayam, Reference: Yogagrantham, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
H/O Type II Diabetes Mellitus
Microalbuminuria levels between 30 to 299 mg/dl
HbA1c more than 6.5% |
|
| ExclusionCriteria |
| Details |
Patient with Age below 18 and above 75 years
Patient with H/O Type 1 DM
Type II DM on insulin therapy
Type II DM along with hypertension and under Anti-hypertensive Medication
Microalbuminuria levels more than 300 mg/dl
Pregnant and lactating mothers
Microalbuminuria induced due to other diseases – Pregnancy, CKD
Patient with other complication of DM–Ketoacidosis, Diabetic nephropathy
Any other Systemic illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Microalbuminuria levels
|
criteria will be assessed on 31st days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in FBS and PPBS levels
Reduction in symptoms like Prabhoot Mutrata
Pipasaadhikya
Kshudhaadhikya
Klama |
criteria will be assessed on 31st days |
|
|
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)
|
03/09/2024 |
| 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="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
|
India ranks top amongst diabetic sufferers. 8.5% of adults aged 18 years and older had Diabetes mellitus. Indian prevalence of diabetic nephropathy ranges from 0.9% to 62%. 10 years after diagnosis of DM the prevalence rate is 25%. In Chennai Urban Rural Epidemiology Study (CURES) people with a history of diabetes had a higher prevalence rate of microalbuminuria and Diabetic Nephropathy. In the survey of National Health and Nutrition Examination Survey (NHANES) and Kidney Early Evaluation Program only 9% of patient were aware of Diabetic Nephropathy and DKD (Diabetic Kidney Disease). A 12 years observational study reported that 44% of people with Type 2 DM developed proteinuria during follow up. Prameha is a disease involving Tridosha as well as all the Dhatus such as Meda, Rasa, Rakta, Mamsa, Vasa, Lasika, Majja, Shukra and Ojas (except Asthi Dhatu). Mainly Kapha Dosha and Meda Dhatu involves in the Samprapti of Prameha. If Prameha is untreated for long period of time it converts in to Madhumeha. Type II DM caused by insulin antagonism can be correlated with Avaran Janya Madhumeha. Microalbuminuria pathology starts with glycation of efferent arteriole. In samprapti of Prameha,Dushti of Kapha dosha leads to all Dhatu Dushti, Bahu Drava Kapha afflicts Meda dhatu. Kapha along with Meda Dhatu creates Avaran and develops Dhatu Shaithilya. Therefore glycation can be compared with Kapha and Meda janya Avaran.In Contemporary medicine Antihypertensive drugs are employed for treatment of microalbuminuria therefore patient should depend on both Anti-hypertensive and Anti-diabetic drugs. Here we are exploring single medication which target both diabetes as well as Microalbuminuria. According to the Study,the diabetic rats treated with Aragwadadi Kashayam at the dose level 200 and 400 mg/kg showed significant (p<0.001) decrease in Microalbuminuria levels,FBS, PPBS.A study concluded that a significant improvement was observed in Microalbuminuria level,fasting blood sugar level and post prandial glycemic level, and reported reduction in excessive urination of patients treated with Aragwadhadi kashayam.Aragwadhadi Kashayam is much effective in improving kidney function and preventing progression of diabetic nephropathy. Various formulation have been described in ayurveda classics which are having effect on Madhumeha and Triphaladi Kashayam is one of them.For treatment of microalbuminuria and Avaranjanya Madhumeha drug should have the properties of Kapha Medo Haram ,Kleda shoshanam, Agnideepan, Amapachana and Rukshanam. Triphaladi Kashayam is a formulation which contains Triphala (Amalaki,Vibhitaki, Haritaki) ,Aragwadha and Draksha having all this properties.So it is hypothesized that it will act in breaking down the samprapti of madhumeha and microalbuminuria. Hence this work entitled "A RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIPHALADI KASHAYAM ON MICROALBUMINURIA LEVELS IN TYPE II DIABETES MELLITUS(MADHUMEHA†is planned. |