| CTRI Number |
CTRI/2021/08/035613 [Registered on: 12/08/2021] Trial Registered Prospectively |
| Last Modified On: |
11/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of chronic kidney disease |
|
Scientific Title of Study
|
Role of Guduchyadi vasthi and Pathyapunarnavadi churna in the management of Jirna Vrikka roga(Chronic kidney disease)
A Randomized standard controlled comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anu Krishna P |
| Designation |
Kayachikitsa PG Scholar |
| Affiliation |
TGAMC and Hospital Bellary |
| Address |
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Bellary
KARNATAKA
583101
India |
| Phone |
9539143396 |
| Fax |
|
| Email |
anukrishna.iijeesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhava Diggavi |
| Designation |
MD(Ayu) Jamnagar Professor and Head |
| Affiliation |
TGAMC and Hospital Bellary |
| Address |
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Bellary
KARNATAKA
583101
India |
| Phone |
9844094290 |
| Fax |
|
| Email |
drmvdbly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Krishna P |
| Designation |
Kayachikitsa PG Scholar |
| Affiliation |
TGAMC and Hospital Bellary |
| Address |
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Department of PG Studies in Kayachikitsa
Taranath Government Ayurvedic Medical College and Hospital
Dr.Rajakumar road Bellary 583101
Bellary
KARNATAKA
583101
India |
| Phone |
9539143396 |
| Fax |
|
| Email |
anukrishna.iijeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PG studies in kayachikitsa Room no 3,Pandith Taranath Govt Ayurveda medical college and Hospital Ballari
DrRajakumar Road 583101 |
|
|
Primary Sponsor
|
| Name |
Pandith Taranath Govt Ayurveda medical college and Hospital Ballari |
| Address |
Pandith Taranath Govt Ayurveda medical college and Hospital
Ballari DrRajakumar Road 583101
|
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anu Krishna P |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
TARANATH GOVERNMENT AYURVEDIC MEDICAL COLLEGE, BELLARI
Dr Rajkumar road,583101
Bellary
KARNATAKA |
9539143396
anukrishna.iijeesh@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TGAMCIEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: Vrikka roga, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Modern management | Dialysis and other oral medicines | | 2 | Comparator Arm | Procedure | - | AsthApana-bastiH/ nirUha-bastiH आIथापन-बEFः/ िनKह-बEFः | (Procedure Reference: AH SU 19 th chapter, Procedure details: Koshta shodhana-Hareethakyadi churna
Dose -12 gm
Time of administration - empty stomach morning 8 am,Sahapana- warm waterfor 5 days
Vasthi -Guduchyadi kashaya 300 ml mixed with Vaiswanara churna 20g will be administered per rectally as per ayugma vasti schedule.
Empty stomach,Left lateral Position
Vasti putaka method.For 8 days
Oral drug- Pathyapunarnavadi churna
Dose – 2gm
Time of administration – thrice in a day
Before food
Sahapana - Takra for 30 days
)
(1) Medicine Name: Pathyapunarnavadi churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Duration: 30 Days |
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)All patients diagnosed as CKD
2)Patients having serum creatinine less than
5mg/dl 3)Patients with serum urea less than
85mg/dl
4)Patients who are fit for vasthi karma
5)Patients irrespective of religion,sex, socio economic status , occupation etc
6)Patients having Haemoglobin >8 gm%
7)Who signed the informed consent.
|
|
| ExclusionCriteria |
| Details |
1)Patients with multi organ failure
2)Patients who are on dialysis thrice in a week
3)Pregnancy,soothika will be excluded
4)Who are not fit for vasti karma will be excluded.
5)Patient with HIV ,HbsAg positive will be excluded.
6)Patient with Serum Creatinine >5 mg/dl, Serum Urea > 85 mg/dl, Haemoglobin <8 gm%
7)Who doesn’t sign for informed consent
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Decrease in Serum Urea,Serum creatinine
2)Improvement in Hb
3)Relief from symptoms |
43 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)Decrease in Serum Urea,Serum creatinine
2)Improvement in Hb
3)Relief from symptoms |
13 days |
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| 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="0"
Months="1"
Days="13" |
|
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
|
Chronic kidney disease is one of the major clinical problem in speciality practice in the current scenario. Multiple factors are responsible for the manifestation of chronic kidney disease, however diagnosing the exact cause is not easy. It is also encountered as upadrava of hridroga and systemic hypertension, sometimes it is also reported to be drug induced. Initially the disease is asymptomatic later symptoms like pedal edema,anaemia,loss of appetite, tiredness and dyspnea are developed. Increasing number of patients presented signs and symptoms of Chronic kidney disease in Ayurvedic Kayachikitsa consultation has raised research question that whether it is possible to have a management module for such cases, either with modern medical intervention or as an add on therapy along with dialysis. Hareethakyadi churna containing Hareetaki, Amalaki, Nisha, Saindhava, Vacha, Guda Pippali, Sunti,Vidanga which act as deepana,pachana,koshtashodhana,shothahara,pro metabolic anti-oxidant and nephron regeneration enzymatic action enhancer.Acharya Charaka has instructed to administer this yoga before the intervention of rasayana karma,hence in the present study this yoga is used as a poorvakarma for shodhana and rasayana chikitsa.
Vasthi is ardha chikitsa in Kayachikitsa speciality.It is trans rectal administration of judicial combination of shodhana drugs targeting dosha prathyanika chikitsa for vata dosha in particular.Invariably CKD is vatasthane kledavridhi hence utklishta dosha should be eliminated by nearest route for which ayugma vasti in yoga vasti schedule is selected to avoid snigdha oushadhis which may hamper ama kleda shotha harana effect. Guduchyadi Kashaya contains Guduchi, padmaka, arishta, dhanyaka, raktachandana, it has a judicial combination of Tridoshahara, Raktaprasadaka, ama kleda meda shothahara tikta gana dravyas in all of them are rasayana in nature,hence will act as sapthadhathu poshana tiktapoushtika.When administered per rectal will bypass digestion and metabolism and directly the virya of dravya will spread in samana apana vyana sthana,hence it is administered per rectaly with vaiswanara churna6 which is a sodium based ushna katu tikta shothahara pandughna meda kledahara kalpa. Pathyapunarnavadi churna is a poly herbomineral compound containing many of rasayana dravyas as Pathya,Punarnava,Guduchi,Bringaraja, Badara, Bala, Chitraka, Sunti, Kitta churna, Ajamoda in one kalpa which are tikta poushtika, Balya, Shothahara, Dhatwagni deepana. OBJECTIVES OF THE STUDYPED 1) To study Jirna vrikka roga,Chronic kidney disease in detail along with critical understanding of pathophysiology of chronic kidney disease. 2) To document and analyse the effect of ongoing modern medical intervention of CKD. 3) To evaluate the effect of guduchyadi vasti and pathyapunarnavadi churna in the management of Chronic kidney disease. 4) To compare the effect of modern medical intervention with ayurvedic guduchyadi vasti and pathyapunarnavadi churna. DESIGN OF THE STUDY:G IN THE MANAGEMENT OF CHRONIC Study design – randomised standard controlled single blinded study Study type – both interventional and observational,Prospective Estimated enrolment –30 Allocation – randomised Intervention model – double group assignment Masking – single blinded Primary purpose – treatment Duration of study – 43 days Follow up - 14 days after treatment OBJECTIVE PARAMETER v Blood – Serum urea § Serum creatinine § Hb% ,TC, DC, ESR § RBS § CRP § Serum Calcium,Sodium,Pottassium,Chloride v Albuminuria v Chest X-Ray Blood Pressure
| DOURBALYA - Severity | Grading | | No tiredness | 0 | | Occasional feeling of tiredness on light activity | 1 | | Constant feeling of tiredness on heavy activity | 2 | | Feeling tiredness all the time | 3 | | aruchi - Severity | Grading | | No Aruchi | 0 | | Mild,without altering eating habits | 1 | | Oral inatake without causing any weight loss | 2 | | Associated with significant weight loss | 3 | | Not relieved by medication | 4 |
swasakrchratha - Severity | Grading | | No breathlessness | 0 | | Breathlessness on upstairs/quick moving | 1 | | Breathlessness on light physical work | 2 | | Breathlessness on bed | 3 |
| AGNIMANDYA - Severity | Grading | | Take full diet and proper appetite at next meal hour | 0 | | Moderate appetite at next meal hour | 1 | | Delayed moderate appetite at next meal hour | 2 | | Delayed low appetite at next meal hour | 3 |
| PADASOPHA - Severity | Grading | | No sopha | 0 | | Slight pitting 2mm,disappears rapidly | 1 | | Deep pitting 4mm ,disappears 10-15 sec | 2 | | Deeper pitting 6mm may last > 1min | 3 |
| PANDU - Severity | Grading | | No pallor | 0 | | Pallor of conjunctiva and or mucous membrane | 1 | | Pallor of conjunctiva,mucous membrane,skin | 2 | | Pallor of conjunctiva,mucous membrane,skin,palmar creases | 3 |
| AROHANA AYASA - Severity | Grading | | No arohana ayasa | 0 | | Arohana ayasa on heavy activity | 1 | | Arohana ayasa on light activity | 2 | | Arohana ayasa on all activities | 3 | | MUTRAKSHAYA - Severity | Grading | | No mutrakshaya | 0 | | Reduced Urine Output With less Water intake | 1 | | Reduced Urine Output Even with more water intake | 2 | | Not Relieved By Medication | 3 | |