1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [semwalabhishek5@gmail.com].
   


6. For how long will this data be available start date provided 10-01-2023 and end date provided 10-01-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

The present synopsis entitled “A Pilot Study To Evaluate The Effect Of An Ayurvedic Regimen In The Cases Of Chronic Kidney Disease”

AIM OF THE RESEARCH PROJECT

To evaluate the effect of Ayurvedic Regimen in cases of chronic kidney disease.

OBJECTIVES OF THE RESEARCH PROJECT

·         To evaluate the effect of indigenous formulations in the management of CKD.

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

·         To assess the side effect of trial drugs if any

PLAN OF STUDY

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

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

Inclusion Criteria 

·         Age- 35-65 years

·         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

·         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 and below 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.    मूत्रावरोध

2.    मूत्रकृच्छता

3.    मूत्रदाह

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.    मूत्राल्पता (Oliguria)

4. 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

Type of study: Pilot Study

Period of study: 90 Days

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

Duration: 90 days

Follow up during treatment = D15, D30, D45, D60, D75, D90

Follow up after treatment = 7 days (without drug) 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 above 40mg/dl and below 101mg/dl and GFR ≤ 90ml/min/1.73m2 and ≤ 30mg/dl and BUN above18.6 mg/dl and below 46.8mg/dl since last 3 months will be selected from OPD & IPD of state ayurvedic college and hospital Lucknow irrespective of their cast, sex or religion.

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

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

Patients will be given Gokshuraadi guggulu, MGH Yoga & Trina panchamoola kwatha

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

·         Dose of Mutraghata Har Yoga – 2 Tab 500mg (Twice Daily) after meal

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

OUTCOME ASSESSEMENT

1.     Relieved

             I.        Patients having 76-100 % relief in terms of symptoms

           II.        ≥ 50% improvement in initial value of essential objective criteria.

 2.    Improved

Patients having improvement between 51-75% in clinical symptoms.

·         Mild Improvement-

                             I.        Improvement between 51-63.5% in clinical symptoms.

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

·         Moderate Improvement

                             I.        Improvement between 63.5-75% in clinical symptom

                           II.        ≥25% and <49.9% improvement in initial value of essential objective criteria

 3.   Unchanged-

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

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

4.    Worsened-

             I.        Patients having no improvement in terms of clinical symptoms.

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