Diabetic NephropathyNCT02477163
Ayurvedic Management of Chronic Kidney Disease
A study testing Ayurveda treatment in people with Diabetic Nephropathy and Hypertensive Nephropathy, run by J.S. Ayurveda College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Nephropathy, Hypertensive Nephropathy
- What is being tested?
- Ayurveda treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2014to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Nephropathy, Hypertensive Nephropathy
- Being tested
- Ayurveda treatment
- Keywords
- Nephropathy, Chronic Renal Failure, Chronic Kidney Disease, Chronic Renal Disease, Ayurveda, Herbal treatment
- Medical subject headings
- Diabetic Nephropathies, Hypertensive Nephropathy, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayurveda treatmentOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | Patients of chronic renal failure Receives: Other: Ayurveda treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJan 2014
- Primary completion30 Jun 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post design
- Masking
- None (open label)
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- J.S. Ayurveda College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manishkumar V Patel, MD(Ayurveda), Principal investigator, J S Ayurveda College,College Road, Nadiad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477163
- Sponsor's protocol ID
- JSAM/IECHR/13-14/362-2
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2015
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02477163
- Acronym / sponsor ID
- JSAM/IECHR/13-14/362-2
- Conditions
- Diabetic Nephropathy, Hypertensive Nephropathy
- Keywords
- Nephropathy, Chronic Renal Failure, Chronic Kidney Disease, Chronic Renal Disease, Ayurveda, Herbal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- J.S. Ayurveda CollegeUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post design
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Other: Ayurveda treatmentPatients of chronic renal failure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayurveda treatment1. 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. | Other | single group |
Primary outcome
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manishkumar V Patel, MD(Ayurveda) principal investigator
J S Ayurveda College,College Road, Nadiad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayurveda treatment in people with Diabetic Nephropathy and Hypertensive Nephropathy, run by J.S. Ayurveda College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the signs and symptoms (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.