We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ayurvedic Management of Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02477163
Recruitment Status : Recruiting
First Posted : June 22, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
J.S. Ayurveda College

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.

Condition or disease
Diabetic Nephropathy Hypertensive Nephropathy

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources




Primary Outcome Measures :
  1. Improvement in the signs and symptoms [ Time Frame: 4 weeks ]

    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

    1. Oedema: No oedema(0); Slight oedema on lower extremties(1); Severe oedema on lower extrimities(2); Anasarca(3)
    2. General weakness: No weakness(0); Mild weakness(1); Moderate weakness(2); Severe weakness(3)
    3. Loss of appetite: Good appetite(0) Mild loss of appetite(1); Moderate loss of appetite(2); Complete loss of appetite(3)
    4. Nausea / Vomiting: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
    5. Muscle cramps: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
    6. Breathlessness: Absent(0); On fast walking or climbing stairs(1); Sometimes at rest(2); Generally occurs at rest(3)
    7. Hiccup: Absent(0); Occasional(1); Once or twice a week(2); Daily(3)
    8. Pruritus: Absent(0); Mild(1); Moderate(2); Severe(3)

  2. Changes in the value of laboratory investigations [ Time Frame: 4 weeks ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from the out-patient and in-patient department of the P D Patel Ayurveda Hospital, Nadiad, India where the patients came from every corner of the India.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477163


Contacts
Contact: Manishkumar V Patel, MD(Ayurveda) +91 0268 2520724 ext 149 manishayu97@yahoo.com
Contact: Kalapi B Patel, MD(Ayurveda) +91 0268 2520724 ext 148 drkalapi@rediffmail.com

Locations
India
P D Patel Ayurveda Hospital Recruiting
Nadiad, Gujarat, India, 387001
Contact: Manishkumar V Patel, MD(Ayurveda)    9979589865    manishayu97@yahoo.com   
Sponsors and Collaborators
J.S. Ayurveda College
Investigators
Principal Investigator: Manishkumar V Patel, MD(Ayurveda) J S Ayurveda College,College Road, Nadiad

Responsible Party: J.S. Ayurveda College
ClinicalTrials.gov Identifier: NCT02477163     History of Changes
Other Study ID Numbers: JSAM/IECHR/13-14/362-2
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016

Keywords provided by J.S. Ayurveda College:
Nephropathy induced by drugs medicaments and biological substances
Other nephritis and nephropathy not specified as acute or chronic

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases