| CTRI Number |
CTRI/2020/02/023290 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of pratham triphala rasayan in mutraghat |
|
Scientific Title of Study
|
Randomized, Controlled, Clinical Study to evaluate the efficacy of Pratham Trifala Rasayana as adjuvant therapy in Mutraghata with special reference to Chronic Renal Failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjivani Jadhao Rathod |
| Designation |
Assistant Professor |
| Affiliation |
MUHS Nashik |
| Address |
Ayurved seva sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8007229141 |
| Fax |
02532517170 |
| Email |
sanjivanirathod431@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Kulkarni |
| Designation |
Professor |
| Affiliation |
MUHS Nashik |
| Address |
Kayachikitsa OPD No 14
Arogyashala Rugnalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8007229141 |
| Fax |
02532517170 |
| Email |
vaidyarajankulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjivani Jadhao Rathod |
| Designation |
Assistant Professor |
| Affiliation |
MUHS Nashik |
| Address |
Kayachikitsa OPD No 14
Arogyashala Rugnalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8007229141 |
| Fax |
02532517170 |
| Email |
sanjivanirathod431@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sanghs Ayurved Mahavidyalaya Nashik
Ganeshwadi Panchavati Nashik |
|
|
Primary Sponsor
|
| Name |
Sanjivani Jadhao Rathod |
| Address |
Aarogyashala Rugnalaya Nashik |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanjivani Jadhao Rathod |
Arogyashala Rugnalaya |
Kayachikitsa OPD No 14
Nashik
MAHARASHTRA |
02532512564
02532517170
sanjivanirathod431@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pratham Triphala Rasayan (Haritaki Bibhitaki Amalaki) |
Haritaki 5 gm in the morning empty stomach Bibhitaki 5 gm in the noon before lunch Amalaki 5 gm in the noon after lunch for 90 days with ghee and honey |
| Comparator Agent |
Standard treatment of CKD |
As per the recommended dose suggested by Nephrologyst |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Pre diagnosed patients of CKD of Stage I to III
2. Both sexes male and female.
3. Willing to Consent & Participate.
4. Age 25 to 65 years.
5. Patients having classical sign and symptoms of CKD such as Shotha (oedema), fatigability (weakness), Swaskashtata (Dyspnoea), anannabhilasha (anorexia), Panduta (less haemoglobin) etc.
|
|
| ExclusionCriteria |
| Details |
1. Acute Renal Failure
2. Uremic Coma
3. Known Patients of Renal Artery Stenosis
4. Age < 25 and > 65 years.
5. Patients of Carcinoma
6. Participate in other clinical trial within 30 days prior to this trial.
7. History of previous kidney transplant.
8. HIV and VDRL infected patients will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in urinary output
Reduction in edema
Increase in appetite
Improvement in fatigue |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of CKD |
90 days |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
This study drug along with standerd treatment for chronic renal failure may improve renal function in cases of chronic renal failure as compaired to baseline and may improve renal function renal conditionor slow down the progration of disease and it increases Hb% dhatuwardhana takes place hence general condition is improved. |