Back to resultsAyurvedic Management of Chronic Kidney Disease
Primary Purpose
Diabetic Nephropathy, Hypertensive Nephropathy
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ayurveda treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Nephropathy, Chronic Renal Failure, Chronic Kidney Disease, Chronic Renal Disease, Ayurveda, Herbal treatment
Eligibility Criteria
Inclusion Criteria:
- Patients having a confirm diagnosis of chronic kidney disease with GFR level < 60mL/min and persistent (present for > 3 months) indicates substantial reduction in kidney function. Confirmation of diagnosis with ultrasound of KUB, indicating reduction of kidney size and / or cortico-medullary difference.
Exclusion Criteria:
- Female patients having pregnancy, breast feeding or post-delivery period.
- Patients who are on dialysis treatment from more than 6 months period. Patients who are already operated for renal transplantation and then having nephropathy.
- Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.
Sites / Locations
- P D Patel Ayurveda Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single group
Arm Description
Patients of chronic renal failure
Outcomes
Primary Outcome Measures
Improvement in the signs and symptoms
Following grade score will be used to measure the improvement in all the patients at the initial level and after the treatment.
Grade score of signs and symptoms
Oedema: No oedema(0); Slight oedema on lower extremties(1); Severe oedema on lower extrimities(2); Anasarca(3)
General weakness: No weakness(0); Mild weakness(1); Moderate weakness(2); Severe weakness(3)
Loss of appetite: Good appetite(0) Mild loss of appetite(1); Moderate loss of appetite(2); Complete loss of appetite(3)
Nausea / Vomiting: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Muscle cramps: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Breathlessness: Absent(0); On fast walking or climbing stairs(1); Sometimes at rest(2); Generally occurs at rest(3)
Hiccup: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Pruritus: Absent(0); Mild(1); Moderate(2); Severe(3)
Changes in the value of laboratory investigations
All the related laboratory investigations will be done before and after the treatment. Effect will be assessed with the help of reduction level in serum creatinine(in mg /dl), blood urea(in mg/dl), serum uric acid(in mg/dl) and improvement in hemoglobin(in gm%) and serum electrolytes level(in mmol/l).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02477163
Brief Title
Ayurvedic Management of Chronic Kidney Disease
Official Title
An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
J.S. Ayurveda College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment in the patients of various types of chronic kidney disease.
Detailed Description
Ayurvedic treatment includes some complex classical herbal formulations and Niruha basti (procto-colonic administration of ayurvedic medicines mainly contained decoction of punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given to the patients of chronic kedney disease who are not on dialysis. Patients of CKD of various etiology will be grouped accordingly and will get the same treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Hypertensive Nephropathy
Keywords
Nephropathy, Chronic Renal Failure, Chronic Kidney Disease, Chronic Renal Disease, Ayurveda, Herbal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
521 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single group
Arm Type
Experimental
Arm Description
Patients of chronic renal failure
Intervention Type
Other
Intervention Name(s)
Ayurveda treatment
Intervention Description
Gokshuradi Guggulu (compound Ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikatu + Musta) - 1 g, 3 times in a day after food with warm water.
Varunadi kvath (ingredients: Varuna tvak + Bilva moola + Apamarga + Chitrak moola + Arani + Shigru + Bruhati + Kirattikta + Karanja + Shatavari) - 40 ml 2 times in a day after food.
Rasayan Churna (powder of Gokshura + Amalaki + Guduchi in equal quantities ) - 3 g, 3 times a day with water.
Bhumyamalaki (Tamalaki Rasayan) tablet - 1 g, 2 times in a day after food with water.
Uricare (of Punarvasu Pharmacy, Petlad road, Nadiad) tablet - 1 g, 3 times in a day after food with warm water.
Niruha Basti (procto-colonic administration of ayurvedic medicine) with Punarnavadi kvath (decoction) - in the morning, before one hour of the lunch.
Primary Outcome Measure Information:
Title
Improvement in the signs and symptoms
Description
Following grade score will be used to measure the improvement in all the patients at the initial level and after the treatment.
Grade score of signs and symptoms
Oedema: No oedema(0); Slight oedema on lower extremties(1); Severe oedema on lower extrimities(2); Anasarca(3)
General weakness: No weakness(0); Mild weakness(1); Moderate weakness(2); Severe weakness(3)
Loss of appetite: Good appetite(0) Mild loss of appetite(1); Moderate loss of appetite(2); Complete loss of appetite(3)
Nausea / Vomiting: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Muscle cramps: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Breathlessness: Absent(0); On fast walking or climbing stairs(1); Sometimes at rest(2); Generally occurs at rest(3)
Hiccup: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
Pruritus: Absent(0); Mild(1); Moderate(2); Severe(3)
Time Frame
4 weeks
Title
Changes in the value of laboratory investigations
Description
All the related laboratory investigations will be done before and after the treatment. Effect will be assessed with the help of reduction level in serum creatinine(in mg /dl), blood urea(in mg/dl), serum uric acid(in mg/dl) and improvement in hemoglobin(in gm%) and serum electrolytes level(in mmol/l).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients having a confirm diagnosis of chronic kidney disease with GFR level < 60mL/min and persistent (present for > 3 months) indicates substantial reduction in kidney function. Confirmation of diagnosis with ultrasound of KUB, indicating reduction of kidney size and / or cortico-medullary difference.
Exclusion Criteria:
Female patients having pregnancy, breast feeding or post-delivery period.
Patients who are on dialysis treatment from more than 6 months period. Patients who are already operated for renal transplantation and then having nephropathy.
Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manishkumar V Patel, MD(Ayurveda)
Organizational Affiliation
J S Ayurveda College,College Road, Nadiad
Official's Role
Principal Investigator
Facility Information:
Facility Name
P D Patel Ayurveda Hospital
City
Nadiad
State/Province
Gujarat
ZIP/Postal Code
387001
Country
India
12. IPD Sharing Statement
Learn more about this trial
Ayurvedic Management of Chronic Kidney Disease
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