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CTRI Number  CTRI/2024/05/067075 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management For Diabetic Induced Nephropathy: A Clinical Trial 
Scientific Title of Study   Clinical Trial To Study The Effect Of Ayurvedic Treatment In The Management Of Diabetic Nephropathy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gaurav Methil 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa,National Institute of Ayurveda,Deemed to be University, Near Jorawar Singh Gate,Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7023205473  
Fax    
Email  gauravm702320@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish Bhakuni  
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa,National Institute of Ayurveda,Deemed to be University, Near Jorawar Singh Gate,Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7891233108  
Fax    
Email  harishbhakuni78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish Bhakuni  
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa,National Institute of Ayurveda,Deemed to be University, Near Jorawar Singh Gate,Amer Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7891233108  
Fax    
Email  harishbhakuni78@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda,Deemed to be University,Jaipur 302002, Rajasthan,India 
 
Primary Sponsor  
Name  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Near Jorawar Singh Gate,Amer Road Jaipur 302002,Rajasthan,India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Methil  Hospital,National Institute of Ayurveda, Deemed to be University, Jaipur  OPD No 1,18,22,25 Hospital,National Institute of Ayurveda,Deemed to be University,Near Jorawar Singh Gate,Amer Road Jaipur 302002,Rajasthan.
Jaipur
RAJASTHAN 		 7023205473

gauravm702320@gmail.com 
Dr Gaurav Methil  Seth Surajmal Bombaywala Ayurvedic Hospital  OPD No.1,Seth Surajmal Bombaywala Ayurvedic Hospital,Kishanpole Bazar Road, Kishanpole Bazar,Jaipur 302007
Jaipur
RAJASTHAN 		 7023205473

gauravm702320@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of National Institute of ayurveda, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N183||Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gandharvahastadi eranda Sneha, Reference: Ashtanga Sangraha Vidradhi Chikitsa15/21, Route: Oral, Dosage Form: Taila, Dose: 40(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Punarnavastaka Kwatha, Reference: Chakradatta Samhita Udarchikitsa 37/51, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 53 Days, anupAna/sahapAna: No, Additional Information: -
(3) Medicine Name: Punarnavadi Mandura, Reference: Bhaisajyaratnavali Pandurogadhikar 12/63, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 53 Days, anupAna/sahapAna: Yes(details: Punarnavastaka Kwatha), Additional Information: -
(4) Medicine Name: Gokshuradi Guggulu, Reference: Sharangdhar Samhita Madhyama Khand Vatak Kalpam 7/84, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5, anupAna/sahapAna: No, Additional Information:
2Intervention ArmDrugOther than Classical(1) Medicine Name: RASAYANA GHAN VATI, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 53 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: -
3Intervention ArmProcedure-AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः (Procedure Reference: Charak Sutra 4/35, Procedure details: Mutravirechaniya mahakashaya niruha basti 500 ml Niruha basti (Empty Stomach) )
(1) Medicine Name: Mutravirechaniya mahakashaya, Reference: Charak Sutra 4/35, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 6 Days
4Intervention ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: सहस्रयोग तैल योग प्रकरण , Procedure details: Dhanvantara Taila anuvasana basti 120 ml Anuvasana basti (After meals) )
(1) Medicine Name: Dhanvantara Taila, Reference: सहस्रयोग तैल योग प्रकरण, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients having any clinical signs and symptoms of chronic kidney disease.
2.Patients with Blood pressure less than 160/100 mm of hg.
3.Patients of Serum creatinine level 1.2 to 6.5mg/dl.
4.Patients of Blood urea level 48 to 180 mg/dl.
5.Patients with Haemoglobin(Hb) greater than 7gm/dl.
6.Patients with HbA1C less than 9%.
7.Patients with GFR level less than 60 ml/min/1.73m² and persistent(present for greater than 3 months).
 
 
ExclusionCriteria 
Details  1.Patients who are on dialysis treatment from more than 1 month period.
2.Patients who are already operated for renal transplantation.
3.Patients of end stage renal failure.
4.Patients of hepatorenal insufficiency or renal insufficiency due to hemodynamic circulatory disorders and CCF.
5.Female patients having pregnancy, breast feeding or post delivery period.
6.Patients some serious illness like cardiovascular diseases, acute mental disorders, serious acute organic diseases, serious chronic comorbidity, hypo or hyperthyroidism, liver or metabolic disorders etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Renal Function Test   From baseline value at the end of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in Fasting blood sugar levels and HbA1c levels.
2.Changes in Hb level.
3.Changes in Urine output levels.
4.Changes in Symptoms of DN.

 		 From baseline value at the end of 8th week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Diabetic kidney disease (DKD) also referred to as diabetic nephropathy. The patients with diabetes and chronic kidney disease (CKD) presented a unique cohort of DKD population, which is identified by elevated urine albumin excretion or reduced glomerular filtration rate (GFR) or both.1 It affects the kidney function and alters the usual process of removal of waste products and excess fluid from the body. Sign and symptoms of kidney disease in people with diabetes include albuminuria (excretion of albumin in the urine), weight gain, swelling of ankle and legs, frequent urination in the night, morning sickness, anaemia, and high blood pressure.

Chronic kidney disease (CKD) also known as chronic Renal failure (CRF), is progressive loss in kidney function over a period of months or years. The symptoms of worsening kidney function are not specific and might include feeling generally unwell. The definition of chronic kidney disease has been simplified over the last 5 years. Diabetic nephropathy is a serious complication of type 1 diabetes and type 2 diabetes. Diabetic nephropathy affects the kidney ability to do their usual work of removing waste products and extra fluid from your body. The best way to prevent or delay diabetic nephropathy is by maintaining a healthy lifestyle and adequately managing your diabetes and high blood pressure.

The National Kidney Foundation - Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) working group has defined CKD as - The presence of markers of kidney damage for more than 3 months, as defined by structural or functional abnormalities of the kidney with or without decreased glomerular filtration rate (GFR), manifest by either pathological abnormalities or other marker of kidney damage, including in the composition of blood or urine or abnormalities in the imaging tests; or The presence of GFR less than 60 ml/1.73 m2 for more than 3 months with or without other signs of kidney damage. 

RESEARCH QUESTION : Whether Ayurvedic treatment protocol, incorporating Sodhana and Shamana Chikitsa, is clinically effective for patients of Diabetic Nephropathy?

AIMS: To assess the clinical effect of Ayurvedic treatment for patients of Diabetic Nephropathy.


 OBJECTIVES

•       Primary objective -To find out the effect of Ayurvedic treatment on the changes of eGFR and other kidney functions in the patients of DN.

•       Secondary objective- To determine the effect of Ayurvedic treatment in DN symptoms and reducing the severity of DN.

 HYPOTHESIS

 Null Hypothesis (H0): Ayurvedic treatment does not have effect in the management of  Diabetic Nephropathy.

Alternative Hypothesis (H1): Ayurvedic treatment has effect in the management of                         Diabetic Nephropathy.


                   DIAGNOSTIC CRITERIA


 

Criteria for DN: Either of the following present for > 3 months

 

 

 

 

 

 

Markers of kidney damage

(one or more)

·       Albuminuria (ACR > 300mg/g)

 

·       Urine sediment abnormalities

 

·       Electrolyte and other abnormalities due to tubular disorders.

 

·       Raised serum creatinine and blood urea level

 

·       Structural abnormalities detected by USG KUB (if necessary for confirmation or differential diagnosis)

·       History of kidney transplantation.

 

·      Decrease GFR (GFR < 60ml/min/1.73 m2)

     

Study Design:The present study is supposed to be-

 

o   Level of study : Department of Kayachikitsa, National Institute of Ayurveda,Jaipur - 302002

o   Study type       : Interventional ,Single ,Randomized Comparative clinical

o   Method of Randomization: Computer generated randomization

o   Purpose                      :    Treatment

o   Masking                     :     Open label

o   Timing                        :     Prospective

o   End point                   :     Efficacy

o   Number of groups     :     Single

   o Number of patients    :      30

       o   Duration of study      :      60 days


Administration of Drug: 

Study time

Interventions

Dose

Timing

 

3 Days

Gandharvahastadi eranda                              Sneha

 

40 ml at night

At bed time (After meals)

 

 

16 Days (Day 4 to Day19)

Mutravirechaniya mahakashaya niruha basti

 

Dhanvantara Taila anuvasana basti (Kaala Krama)

 

 

500 ml Niruha basti, 120 ml Anuvasana basti

 

Niruha basti – (Empty Stomach) Anuvasana Basti (After meals)

Day 4 to Day 60

Punarnavashtaka Kwatha

40 ml two times a day

(30 min. Before meals)

 

 

Gokshuradi Guggulu

2 Vati each of 250 mg, three times a day, with lukewarm water

 

(30 min. After meals)

 

 

 

Punarnavaddi Mandura

2 Vati each of 125 mg, two times a day, with Punarnavashtaka

Kwatha

 

(30 min. Before meals)

 

 

Rasayana Ghan Vati

2 Vati each of 250 mg, two times a day,

with lukewarm water

 

(30 min. After meals)

  Duration of clinical trial and follow study
    
  o   Total duration of trail for - 60 days

o   Follow up – After completion of the treatment, all the patients will be followed up every 2 weeks in OPD to observe further changes in anaemia profile of the disease. All above oral medicaments will be continued during follow up period. 

                                                                   Criteria for withdrawal

 

•       During the course of trial if any serious condition or any serious adverse effects of occur which required urgent treatment Patient himself wants to withdraw from the clinical trial.

•       Individuals who are unable or unwilling to comply with the study procedures and follow-up visits.

•       Patients complaining of any adverse reaction or severe complications or any other symptoms of intolerance will be withdrawn from the study.

       Criteria of Assessment:

•       Subjective Criteria:

 

•       Breathlessness (Shvasakrichchhrita)

•       Anorexia (Aruchi)

•       Oedema (Shotha )

•       Generalised Weakness (Daurbalya )

•       Nausea/Vomiting ( Chhardi )

•       Amount of urine ( Mutra Parimana )


·      Objective parameters

The following investigation will be done on 1 day and end of the trial. Following  laboratory investigations will be performed for proper diagnosis and to rule out

major pathologicalconditions:

 

Name of the investigation

Timing for investigation

CBC

Baseline and After 8 weeks treatment

LFT

Baseline and After 8 weeks treatment

RFT

Baseline and After 8 weeks treatment

LIPID PROFILE

Baseline and After 8 weeks treatment

SERUM ELECTROLYTES

Baseline and After 8 weeks treatment

URINE ANALYSIS

Baseline and After 8 weeks treatment

FBS, PPBS & HbA1C

Baseline and After 8 weeks treatment

Statistical Analysis:

 The information will be gathered on the basis of observation made about various parameters will be subjected to statistical analysis in terms of Mean, Standard deviation and Standard error (SE). In Stat Graph Pad 3 software will be used & For Non-parametric Data Wilcox-on matched-pairs signed ranks test will be used, while for Parametric Data Paired ‘t’ Test will be used and results will be calculated. Paired t test will be carried out at p<0.05, p<0.01, p<0.001.

For inter-group comparisons, for the Non-parametric variables will be used Mann- Whitney Test, while for Parametric variables Unpaired ‘t’ Test will be used for statically analysis. The results will be calculated.

•         Non-significant      : P >0.05

•         Significant              : P <0.05

•         Highly significant    : P < 0.01, P < 0.001, P< 0.0001

 

 STUDY OUTCOMES

       PRIMARY OUTCOME - Changes in Renal Function Test from baseline value at the end of 8thweek.

      SECONDARY OUTCOME -

â—‰      Changes in Fasting blood sugar levels and HbA1c levels from baseline value at the end of 8th week.

â—‰      Changes in Hb level from baseline value at the end of 8th week.

â—‰      Changes in Urine output levels from baseline value at the end of 8th week.

â—‰      Changes in Symptoms of DN from baseline value at the end of 8th week.

 

 
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