Ayurvedic Management of Chronic Kidney Disease

August 10, 2022 updated by: J.S. Ayurveda College

An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
521

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Nadiad, Gujarat, India, 387001
        • P D Patel Ayurveda Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: single group
Patients of chronic renal failure
Other: Ayurveda treatment
  1. Gokshuradi Guggulu (compound Ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikatu + Musta) - 1 g, 3 times in a day after food with warm water.
  2. 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.
  3. Rasayan Churna (powder of Gokshura + Amalaki + Guduchi in equal quantities ) - 3 g, 3 times a day with water.
  4. Bhumyamalaki (Tamalaki Rasayan) tablet - 1 g, 2 times in a day after food with water.
  5. Uricare (of Punarvasu Pharmacy, Petlad road, Nadiad) tablet - 1 g, 3 times in a day after food with warm water.
  6. Niruha Basti (procto-colonic administration of ayurvedic medicine) with Punarnavadi kvath (decoction) - in the morning, before one hour of the lunch.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
4 weeks
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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
J.S. Ayurveda College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manishkumar V Patel, MD(Ayurveda), J S Ayurveda College,College Road, Nadiad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSAM/IECHR/13-14/362-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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