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CTRI Number  CTRI/2024/02/062819 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [PH.D. Thesis]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Basti therapy of Ayurveda in chronic kidney disease treatment 
Scientific Title of Study   Add-on effect of Shatavaryadi Basti in comparison with Punarnavadi Basti in the management of chronic kidney disease: A randomized comparative clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahulkar Darshan Mohan 
Designation  PH. D. Scholar, Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Room No 618, Department of Kayachikitsa, 6th floor Academic C block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New DElhi 110076

New Delhi
DELHI
110076
India 
Phone  9834000935  
Fax    
Email  darshanmahulkar71@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Kant Yadava 
Designation  Associate Professor, Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Room No 614, Department of Kayachikitsa, 6th floor Academic C block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New DElhi 110076

New Delhi
DELHI
110076
India 
Phone  7982523098  
Fax    
Email  drrkyadava@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahulkar Darshan Mohan 
Designation  PH. D. Scholar, Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Room No 618, Department of Kayachikitsa, 6th floor Academic C block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New DElhi 110076

New Delhi
DELHI
110076
India 
Phone  9834000935  
Fax    
Email  darshanmahulkar71@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda, New Delhi 
Address  All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New DElhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahulkar Darshan Mohan  All India Institute of Ayurveda  room no. 614, Department of Kayachikitsa, Gautampuri, Sarita Vihar, New Delhi 110076
New Delhi
DELHI 		 9834000935

darshanmahulkar71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N184||Chronic kidney disease, stage 4 (severe). Ayurveda Condition: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Siddhisthana, Procedure details: Purvakarma- Sarvanga mridu Abhyanga with Dhanwantara tail (ref. AFI Part-I, 8-22, Pg. 137) followed by Sarvanga mridu bashpa sweda by Dashamool kwatha (Ref. A.F.I.-B.R.) for daily 15 days. Pradhana karma- Kaal Basti krama (Reference-Ashtanga Hrudayam Sutrasthana Chapter 19 Verse 64) Anuvasana Basti with Vastyamayantak ghrita (Reference-Sahasrayogam) & Nirooh Basti with Shatavaryadi siddha ksheer kwatha (Reference-Charaka Siddhisthana, Chapter 9, Verse 8)) )
(1) Medicine Name: Punarnavashtaka Kwatha, Reference: A. F. I. - 1, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 60 Days
(2) Medicine Name: Gokshuradi Guggulu, Reference: A.F.I., Part-1, Pg. 67-68, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 60 Days
(3) Medicine Name: Shiva Gutika, Reference: Yogaratnakara, Rajayaksmadhikara, page 322, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 60 Days
(4) Medicine Name: Rasayana Churna, Reference: Ashtanga Hrudaya, Uttarasthana Chapter 39, Verse 179, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days
(5) Medicine Name: Pravalapanchamrita Rasa, Reference: A. F. I. - B. R., Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Duration: 60 Days
(6) Medicine Name: Haritaki Churna, Reference: A.P.I. Part 1, Volume 1, Pg. 47, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Duration: 60 Da
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Siddhisthana, Procedure details: Purvakarma- Sarvanga mridu Abhyanga with Dhanwantara tail follwed by Sarvanga mridu bashpa sweda by Dashamool kwatha for daily 15 days pradhana karama- Kaal Basti krama, Anuvasana Basti with Vastyamayantak ghrita & Nirooh Basti with Punarnavashtaka siddha ksheer kwatha)
(1) Medicine Name: Punarnavashtaka Kwatha, Reference: A. F. I. - 1, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 60 Days
(2) Medicine Name: Gokshuradi Guggulu, Reference: A.F.I., Part-1, Pg. 67-68, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 60 Days
(3) Medicine Name: Shiva Gutika, Reference: A.F.I.-1- Yogaratnakara, Rajayaksmadhikara, page 322, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 60 Days
(4) Medicine Name: Rasayana Churna, Reference: Ashtanga Hrudaya, Uttarasthana Chapter 39, Verse 179, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days
(5) Medicine Name: Pravalapanchamrita Rasa, Reference: A. F. I. - B. R., Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Duration: 60 Days
(6) Medicine Name: Haritaki Churna, Reference: A.P.I. Part 1, Volume 1, Pg. 47, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g|), Frequency: , Duration:
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of both genders having age group 21-65 yrs. with confirmed diagnosis of stage up to G4 as per standard KDIGO-CRITERIA, not having undergone RRT were included.
2. Patients under controlled Diabetes and Hypertension with or without conventional medications.  
 
ExclusionCriteria 
Details  1. Patients suffering from Tuberculosis, Malignancy, Pregnancy and lactation, or any other systemic illness.
2. Uncontrolled diabetes and HTN
3. HIV-associated nephropathy and transplant allograph failure
4. Renal Artery stenosis.
5. Neoplasm of Kidney.
6. History of previous kidney transplant.
7. Patients of Congenital Renal Diseases like Autosomal dominant and Recessive Polycystic Kidney disease, Congenital Nephrotic syndrome, Alports syndrome, Fabrys disease and juvenile Nephronophthisis.
8. Patients with other added complications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in values of KFT about 30% from baseline (Sr Creatinine, Blood urea,
Serum Uric acid level)  		 Day 0, 15, 30, 45, 60 and 120 day of Follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life  Day 0, 30, 60 and 120 day of Follow up 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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/ Phase 3 
Date of First Enrollment (India)   23/02/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Chronic kidney disease (CKD) is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2, persisting for 3 months or more, irrespective of the cause. Chronic kidney disease (CKD) refers to a group of pathophysiologic conditions characterized by impaired kidney function and a persistent decline in glomerular filtration rate (GFR). The risk of CKD progression is directly related to both GFR and the level of albuminuria, which gives a CKD staging. Diabetes and hypertension account for more than two-thirds of CKD cases in Western countries, owing to the prevalence of lifestyle disease. Diabetes and hypertension now account for 40-60% of CKD cases in India.

Chronic kidney disease (CKD) is not clearly mentioned in Ayurveda classics, but dispersed fragment of disease can be traced in various chapters, under different heading. While mentioning the genesis of Vrukka (kidney) Sushrut in Sharir Sthan told that it is a Matruj Avayava and it is formed of Rakta and Meda Dhatus. Although there is no description of CKD in Ayurveda Classics as per disease of Mutravaha Srotas, but disease described as per the manifestation from Hetu, dosha, Dhatu Dushti, Lakshana, etc. Hence, CKD is the collaborative progression of Rasavaha, Raktavaha, Mamsavaha, Medovaha-SrotasDusti which reflects through Mutravaha Srotas including Ojas Dusti.
So that line of treatment should be focusing on the vitiation of tissue by Amavisha (Sr.Creatinine and Sr.Urea) by correcting Ojas Dusti, Jatharagni correction , Dhatu Samyata (metabolism) , Rejuvenation of deteriorated cells of Vrukka (Kidney) and remove the toxic substances raised in blood by increasing eGFR as well as break off the progression of disease one stage to another.

·       Primary objective

Reduction in values of KFT about 30% from baseline ((Sr Creatinine, Blood urea, Serum Uric acid level)

· Secondary objective

  1. To improve the hemoglobin, Glomerular Filtration Rate (e-GFR) and reduction in Albuminuria level.
  2. Conceptual understanding of CKD in Ayurveda.
  3. Assessment of signs and symptoms of CKD.
  4. Assessment of quality of life in CKD by-Kidney Disease Quality of Life Short Form (KDQOL-SFâ„¢) 

Total sample size= 84 (approx.) So, 42 patients in each group

Groups: 2

Group A

Group B

Ayurvedic Shamana medicines +

Punarnavadi Basti along with CKD specific diet and lifestyle modifications

Ayurvedic Shamana medicines +

Shatavaryadi Basti along with CKD specific diet and lifestyle modifications

ASSESSMENT CRITERIA

Subjective

•       Signs and symptoms of CKD will be Analyzed in BT, 15th, 30th, 45th, AT and FU. 

•       Quality of life of patients. (KDQOL 36) will be Analyzed in BT, 30th, AT and FU days

Objective

•       Serum creatinine will be Analyzed in BT, 15th, 30th, 45th, AT and after 2-month FU.

•       Blood urea will be Analyzed in BT, 15th, 30th, 45th, AT and after 2-month FU.

•       Hemoglobin will be Analyzed in BT, 15th, 30th, 45th, AT after 2 month and FU.

•       Albuminuria will be Analyzed in BT, 15th, 30th, 45th, AT after 2 month and FU.

•       e-GFR will be Analyzed in BT, 30th, AT and after 2-month FU.

DURATION OF TRIAL

Total duration (clinical trial duration + Follow up duration) = 60+60=120 days.

Visit of patient during trial period on every BT (0), 15, 30, 45, AT (60th) and after every 15 days for two-month FU period (up to 120th day).

END POINTS

Primary- Reduction in biochemical parameters with signs and symptoms.

Secondary- Improvement in quality of life.


 
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