A Study to evaluate the effect of an ayurvedic treatment in the cases of chronic kidney disease

Phase 2

Recruiting

• Conditions: Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: MUTRAGHATAH,

• Registration Number: CTRI/2022/09/045326
• Lead Sponsor: State Ayurvedic College And Hospital Lucknow

Brief Summary

The present synopsisentitled **“A Pilot Study To Evaluate The Effect Of An Ayurvedic Regimen In TheCases Of Chronic Kidney Diseaseâ€**

**AIM OF THE RESEARCH PROJECT**

To evaluate theeffect of Ayurvedic Regimen in cases of chronic kidney disease.

**OBJECTIVES OF THE RESEARCH PROJECT**

·        To evaluate the effect of indigenousformulations in the management of CKD.

·        To assess the effectiveness of thedrugs on selected subjective and objective parameters.

·        To assess the side effect of trialdrugs if any

**PLAN OF STUDY**

**Study Setting:** OPD and IPD of State Ayurvedic College andHospital, Lucknow

**Study population:** Clinically diagnosed patients suffering fromchronic kidney disease will be selected for the purpose of study.

**Inclusion Criteria**

·        Age- 35-65 years

·        History of reduction ofkidney function must be present over 3 months.

·        Serum Creatinine level above 1.4 mg/dl and below4.6 mg/dl

·        Serum Urea level above 40mg/dl and below101mg/dl

·        Patient having Hb level >8gm/dl

·        GFR 30- 90ml/min/1.73m2

·        BUN [Blood urea Nitrogen] above 18.6mg/dl andbelow 46.8mg/dl

**ESSENTIAL CRITERIA**

**Objective Criteria**

1.    Blood Urea

2.    Serum Creatinine

3.    GFR (Glomerular filtration rate)

4.    Blood Urea Nitrogen

 **NON-ESSENTIAL CRITERIA**

A.   **Subjective Non-Essential**

1.    मूतà¥à¤°à¤¾à¤µà¤°à¥‹à¤§

2.    मूतà¥à¤°à¤•à¥ƒà¤šà¥à¤›à¤¤à¤¾

3.    मूतà¥à¤°à¤¦à¤¾à¤¹

4.    Anorexia

5.    Vomiting

6.    Pruritis

7.    Oedema

8.    Nocturia

9.    Thirst

10. Dozing & Sleeplessness

11. Dyspnoea

**B.** **Objective Non-Essential**

1.    Anaemia

2.    Lipid Profile

3.    मूतà¥à¤°à¤¾à¤²à¥à¤ªà¤¤à¤¾ (Oliguria)

**4. Exclusion Criteria**

·        Age below 35 andabove 65 years.

·        Blood Urea more than100mg/dl and below 41mg/dl

·        Serum creatininelevel above 4.5 mg/dl and below 1.5mg/dl

§ BUN [Blood urea Nitrogen] above 46.7mg/dl andbelow 18.7mg/dl

·        GFR < 30ml/min/1.73m2

·        Patients under frequentdialysis

·        Uncontrolled Diabetesmellitus

·        MalignantHypertension

·        Grade III Prostate

·        Prostate Carcinoma

·        Tubercular Nephritis

·        Hypovolemia

·        Liver Failure

·        Heart Failure

·        Acute MyocardialInfarction

·        Sever ValvularDisease

·        Tense Ascites

·        Sepsis

·        Haemorrhage

·        Pancreatitis

·        Renal artery/ veinobstruction

·        Microangiopathies likeDIC, TTP

·        Systemic Disease likelupus, lymphoma, Leukaemia, sarcoidosis

·        Congenital Disease ofkidney ex- Polycystic kidney disease

·        Transplant allograftfailure

**Type of study:** Pilot Study

**Period of study:** 90 Days

**Sample Size:** Minimum 30patients of chronic kidney disease from OPD & IPD of SAC & H will beselected

**Duration: 90 days**

**Follow upduring treatment** = D15, D30, D45,D60, D75, D90

**Follow upafter treatment =** 7 days (withoutdrug) after treatment is completed.

**Selection of subject**

Ø The patients having **Sr.Creatine level above 1.4mg/dl and below 4.6mg/dl, Blood urea level above40mg/dl and below 101mg/dl and GFR ≤ 90ml/min/1.73m2 and ≤ 30mg/dl and BUNabove18.6 mg/dl and below 46.8mg/dl since last 3 months** will be selectedfrom OPD & IPD of state ayurvedic college and hospital Lucknow irrespectiveof their cast, sex or religion.

Ø Patientswho will fulfill all essential criteria with or without non-essential criteriawill be selected for the study

Ø After preliminaryregistration diagnostic medical history will be taken according to both *Ayurveda*and modern clinical methods.

Patients will be given *Gokshuraadi guggulu,* *MGH Yoga &* *Trina panchamoolakwatha*

 Â·        **Dose of** ***Gokshuraadi gugglu:*** ***2 Tab each 250mg,*** **(Twice daily) after meal**

·        **Dose of *Mutraghata HarYoga* – 2 Tab 500mg (Twice Daily) after meal**

·        **Dose of** ***Trina panchamoola kwatha*** **– 40ml (Twice daily) as anupana**

**OUTCOMEASSESSEMENT**

**1.    Relieved**

I.       Patients having76-100 % relief in terms of symptoms

II.       â‰¥ 50% improvementin initial value of essential objective criteria.

**2.   Improved**

Patients having improvementbetween 51-75% in clinical symptoms.

·        **Mild Improvement**-

I.       Improvementbetween 51-63.5% in clinical symptoms.

II.       Upto 24.9%improvement in initial value of essential objective criteria.

·        **Moderate Improvement**

I.       Improvementbetween 63.5-75% in clinical symptom

II.       â‰¥25% and<49.9% improvement in initial value of essential objective criteria

**3**.   **Unchanged-**

I.       Patients havingimprovement less than 50% in terms of clinical symptoms.

II.       Pathologicalfindings (Blood Urea, Serum Creatinine, GFR, BUN) remain same as before trial.

**4.    Worsened-**

I.       Patients havingno improvement in terms of clinical symptoms.

II.       Pathologicalfindings get disturbed (Blood urea and Creatinine level, BUN may get increased& GFR goes down).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-11
• Study Start: 2022-10-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• History of reduction of kidney function must be present over 3 months.
• Serum Creatinine level above 1.4 mg/dl and below 4.6 mg/dl 3.
• Serum Urea level above 40mg/dl and below101mg/dl 4.
• Patient having Hb level >8gm/dl 5.
• GFR 30- 90ml/min/1.73m2 6.
• BUN [Blood urea Nitrogen] above 18.6mg/dl and below 46.8mg/dl.

Exclusion Criteria

• Age below 35 and above 65 years.
• Blood Urea more than 100mg/dl and below 41mg/dl Serum creatinine level above 4.5 mg/dl and below 1.5mg/dl BUN [Blood urea Nitrogen] above 46.7mg/dl and below 18.7mg/dl GFR < 30ml/min/1.73m2 Patients under frequent dialysis Uncontrolled Diabetes mellitus Malignant Hypertension Grade III Prostate Prostate Carcinoma Tubercular Nephritis Hypovolemia Liver Failure Heart Failure Acute Myocardial Infarction Sever Valvular Disease Tense Ascites Sepsis Haemorrhage Pancreatitis Renal artery/ vein obstruction Microangiopathies like DIC, TTP Systemic Disease like lupus, lymphoma, Leukaemia, sarcoidosis Congenital Disease of kidney ex- Polycystic kidney disease Transplant allograft failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Blood Urea	Before trial, 4 week, 8 week, 12th week, after trial
2. Serum Creatinine	Before trial, 4 week, 8 week, 12th week, after trial
3. GFR (Glomerular filtration rate)	Before trial, 4 week, 8 week, 12th week, after trial
4. Blood Urea Nitrogen	Before trial, 4 week, 8 week, 12th week, after trial

Secondary Outcome Measures

Name	Time	Method
•मूतà¥à¤°à¤¾à¤µà¤°à¥‹à¤§	•मà¥à¤¤à¥à¤°à¤•à¥ƒà¤šà¥à¤›à¥à¤°à¥à¤¤à¤¾
Urine Routine and Microscopy	Blood sugar (FBS,PP)

Trial Locations

Locations (1)

State Ayurvedic College and Hospital; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Abhishek Kumar Semwal

Principal investigator

8826179484

semwalabhishek5@gmail.com