| CTRI Number |
CTRI/2021/01/030193 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Panchakarma] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Erandamooladi Basti along with Ayurvedic Multi Drug Therapy in the Treatment of Chronic Kidney Disease |
|
Scientific Title of Study
|
Efficacy of Ayurvedic Multi Drug Therapy along with Erandamooladi Basti in the Management of Chronic Kidney Disease-An Open Labelled Randomized Controlled 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 |
Remya Kuttan |
| Designation |
MD Scholar |
| Affiliation |
IPGT and RA |
| Address |
Department of Panchakarma
IPGT and RA
4th Floor
Jamnagar
Gujarat
Jamnagar GUJARAT 361008 India |
| Phone |
9846793260 |
| Fax |
|
| Email |
remyasijugopal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD and Director |
| Affiliation |
IPGT and RA |
| Address |
Department of Panchakarma
IPGT and RA
4th Floor
Jamnagar
Gujarat
Jamnagar GUJARAT 361008 India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD and Director |
| Affiliation |
IPGT and RA |
| Address |
Department of Panchakarma
IPGT and RA
4th Floor
Jamnagar
Gujarat
Jamnagar GUJARAT 361008 India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Opposite Reliance Smart Department of Panchakarma, IPGT and RA ,GAU , Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA
GAU
Jamnagar
Gujarat India 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Remya kuttan |
PG Hospital IPGT and RA |
Department of Panchakarma
IPGT and RA
4th Floor
Jamnagar
Gujarat Jamnagar GUJARAT |
9846793260
remyasijugopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition:N183||Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Basti along with Ayurvedic Multi drug therapy |
In Group A patients will be given Ayurvedic oral medications and Panchakarma procedure Basti Oral medications include dipana pachana with Trikatu choornam 3-5gm tds for3-5daysfollowed by VarunaSigru Kwath 40ml bd before food Gokshuradiguggulu 2tds before food Guduchyadisamana choornam 3gm bd after food gokshura choornam 3gm bd before food for 20-22 days Panchakarma procedure as Erandamooladi Bastiin which Niruha Basti for 12 days and Anuvasana Basti for 4 days |
| Comparator Agent |
Control group |
Group B consists of standard controlled group taking Allopathic medications throughout the study for 20-25 days.It will include Antihypertensive medications Drug that reduce Metabolic Acidosis Calcium supplements Iron supplements Vitamin B complex medicines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of chronic kidney disease.
2. Patients of both genders between 18-60yrs of age.
3. Patients willing and able to participate.
4. Patients with serum creatinine level between1.2- 6 mg/dl will be included in the study.
5. Patients with serum urea level with in 120mg/dl
6. Patients who are yogya for basti karma.
|
|
| ExclusionCriteria |
| Details |
1. Female patients having pregnancy, breast feeding or post-delivery period.
2. Patients of end stage renal failure.
3. Patients who are on dialysis treatment for more than 1-month period.
4. Patients who are already operated for renal transplantation and then having nephropathy.
5. Patients of hepato-renal insufficiency or renal insufficiency due to hemodynamic circulatory disorders and CCF.
6. Patients having some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism.
7. Patients having haemoglobin concentration below 8gm.
8. Having uncontrolled Hypertension(systolic<180mm/Hg, diastolic<100mm/Hg) and Diabetes mellitus (FBS-<200mg/dl)
9. Patients with serum urea level above 120mg/dl
10. Patients having symptoms of Uremia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum creatinine and increase in eGFR |
After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of CKD |
After 4 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 3 |
|
Date of First Enrollment (India)
|
04/01/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of the Research:
Chronic Kidney Disease
refers to an irreversible destruction of the kidney function persistent for
more than or equal to3months.Prevalence of this disease is about 250 million
people in the world.In India prevalence is about 800 per million population.The
modern management of CKD is worth costly
and the ultimate remedy is renal transplantation.The increase in the prevalence
of kidney disease progressing to End Stage Renal Disease and the consequent financial
burden of renal replacement therapy create imbalance in the economy of
Developing country like India.Moreover,main causes of CKD are Diabetes and
Hypertension.By 2030,India is expected to have worlds largest population of
patients with Diabetes.So it’s a humble
effort to find an alternate treatment for safe,effective as well as cheaper
medication when compared to modern medicine.
The present study aims to asses and compare the effect of Ayurvedic
multi drug therapy along with Erandamooladi Basti in the management
of Chronic Kidney Disease.
Information about Trial
drug and Panchakarma procedure:
The trial drug includes
Kashayam of Varuna Sigru(40ml two times daily ,before food),Gokshuradi
Guggulu(two tab thrice ,before food),Guduchyadi Choornam(5gm
twice,after food)and Gokshuradi Choornam(3gm twice before food)
internally for 20-22 days.The Panchakarma procedure we are testing in
this study is the Erandamooladi Basti(internal administration of
medicated Basti dravya through anal route)for 16 days.The trial drug
formulations used in this study are described in Ayurvedic classical
texts and are prepared from the Pharmacy of Gujrat Ayurved University,Jamnagar and
none of them has reported any side effects.We assure that this formulation has
been prepared with complete care and purification methods if required.
Description of Research
Process:
In the present
study,participants which clinically diagnosed and confirmed cases of Chronic
Kidney Disease will be divided in to two groups,with a minimum of 15 patients
in each group.
Group A:
Participants willing to
take Ayurvedic multi drug therapy and Erandamooladi Basti are
included in Group A.The treatment protocol includes trikatu choornam
3-5gm for 3-5 days for improving digestive power,Gokshura,VarunaSigru kwath di
guggulu,Guduchyadi Samana choornam,Gokshura choornam for 20-22days(doses as
above mentioned).Panchakarma procedure includes internal administration
of medicated Erandamooladi Basti dravya for 12days and Anuvasana
Basti(using medicated thila thaila for 4 days) in the order of three Erandamooladi
Basti (480ml)followed by one thila thaila Basti(60ml).
Group B:
Participants willing to
take conventional medicine(Allopathic)medications are included in this
group.The medications include AntiHypertensive drugs,drugs which reduces
metabolic acidosis,Iron supplements,Vitamin B Complex medications,Calcium
tablets etc.This group considered to be the standard controlled group.
Side Effects:
We will follow closely
and keep track of any unwanted effects .Till now ,no side effects had been
reported on the internal administration
of mentioned trial drugs and the administration of Erandamooiadi Basti
procedure.
Benefits:
This project will help
us to resolve the research question.There may not be any benefit for the
society at this stage of the research,but future generations are likely to be
benefitted,as it helps to find out proper treatment protocol for the management
of Chronic Kidney Disease.
The information that we
collect from this research project will be kept confidential,all outcomes will
be noted in tabular form and appropriate statistical tests will be applied to
compare the effect. |