CTRI/2024/07/070318 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On:
09/07/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Comparative Effect of Basti therapy of Ayurveda in chronic kidney disease treatment
Scientific Title of Study
A clinical study to evaluate the comparative effect of customised Basti and classical Basti in the management of chronic kidney disease (CKD): An exploratory trial
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 Rama Kant Yadava
Designation
Additional Professor
Affiliation
All India Institute of Ayurveda, New Delhi
Address
Room No. 614, Department of Kayachikitsa 6th floor Academic Block All India Institute of Ayurveda (AIIA) Sarita Vihar New Delhi 110076
New Delhi DELHI 110076 India
Phone
9412148437
Fax
Email
drrkyadava@gmail.com
Details of Contact Person Scientific Query
Name
Dr Rama Kant Yadava
Designation
Additional Professor
Affiliation
All India Institute of Ayurveda, New Delhi
Address
Room No. 614, Department of Kayachikitsa 6th floor Academic Block All India Institute of Ayurveda (AIIA) Sarita Vihar New Delhi 110076
New Delhi DELHI 110076 India
Phone
9412148437
Fax
Email
drrkyadava@gmail.com
Details of Contact Person Public Query
Name
Dr Darshan Mohan Mahulkar
Designation
PH. D. Scholar
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 (AIIA)
Address
Gautampuri, Mathura Road, 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 Darshan Mahulkar
All India Institute of Ayurveda
Department of Kayachikitsa, Hospital division, Room No. 5, Gautampuri, Mathura Road, Sarita Vihar New Delhi 110076 New Delhi DELHI
(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)
( Kwath- Shatavaryadi Ksheer Kwath 250 ml, Vastyamayantak Ghritam 60 ml Bala Shtapushpadi Kalka 30 gm Madhu- 50 ml Saindhav- 5 gm for daily 15 days.)) (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 D
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 G3-B 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 the values of KFT (Sr Creatinine, Blood urea, Serum Uric acid level) and
to improve estimated Glomerular Filtration Rate (e-GFR)
KFT assessed at Baseline, 15th, 30th 45th and 60th (AT), after 2-month FU.
e-GFR assessed at BT, AT, after 2-month FU.
Secondary Outcome
Outcome
TimePoints
1. To improve Hb%.
2. To reduce Albuminuria.
3. To improvement in signs and symptoms of CKD
4. Assessment of quality of life by-Kidney Disease Quality of Life Short Form
(KDQOL-SFâ„¢)
5. To analyze electrolyte imbalance.
1. Hemoglobin assessed at BT, 15th, AT, after 2-month FU
2. Albuminuria assessed at BT, 15th, after AT, 2-month FU.
3. Signs and symptoms of CKD at BT, AT, after 2-monthsFU
4. Quality of life of patients at BT, AT, after 2-months FU
5. Sr Electrolyte assessed at BT, 15th, AT, after 2-month FU.
Target Sample Size
Total Sample Size="50" Sample Size from India="50" 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
N/A
Date of First Enrollment (India)
20/07/2024
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)
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
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 the values of KFT (Sr Creatinine, Blood urea, Serum Uric acid level) and to improve estimated Glomerular Filtration Rate (e-GFR)
Secondary objective
1. To improve Hb%.
2. To reduce Albuminuria.
3. To improvement in signs and symptoms of CKD
4. Assessment of quality of life by-Kidney Disease Quality of Life Short Form
(KDQOL-SF)
5. To analyze electrolyte imbalance.
Group A
Customized Basti
Group B
Classical Basti
·Ayurvedic Shamanachikitsa
Customised daily Shatavaryadi for 15 days
CKD specific diet and lifestyle modifications
Ayurvedic Shamanachikitsa
Basti treatment in Kaala Basti*
Krama of Shatavaryadi Basti
CKD specific diet and lifestyle modifications
ASSESSMENT CRITERIA
Subjective
Signs and symptoms of CKD at BT, AT, after 2-monthsFU.
Quality of life of patients at BT, AT, after 2-monthsFU.
Objective
•KFT assessed at BT, 15th, AT, after 2-month FU.
•e-GFR assessed at BT, AT, after 2-month FU.
•Sr Electrolyte assessed at BT, 15th, AT, after 2-month FU.
•Hemoglobin assessed at BT, 15th, AT, after 2-month FU.
•Albuminuria assessed at BT, 15th, after AT, 2-month FU.
DURATION OF TRIAL
·Total duration of trial
(Clinical trial duration + Follow up duration) = 60+60=120 days.
·Visit of patient during trial period on every 0, 15, 30, 45, 60th and after every 15 days up to for follow-up 120th days.
END POINTS
•Primary
•Reduction in biochemical parameters with signs and symptoms.
•Secondary
•Improvement in quality of life.
SAMPLE SIZE: Total 50 Patients, 25 in each group (exploratory trial)