| CTRI Number |
CTRI/2025/01/079531 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Amritadi Kwath and Gokshurak Rasayana in management of Chronic kidney disease w.s.r. Mutravahasrotas Dushti |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Amritadi kwath and Gokshurak Rasayana in management of Chronic kidney disease ( Mutravahasrotas Dusti) - Open Labelled Randomized Control Clinical 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 Anjali |
| Designation |
MD Scholar (Kayachikitsa) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh
South West
DELHI
110073
India |
| Phone |
7015087815 |
| Fax |
|
| Email |
ANJALILANGYAIN08@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh
South West
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh
South West
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sanasthan , Khera Dabar, Najafgarh, Delhi, India
Pincode:110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sanasthan |
| Address |
Khera Dabar, Najafgarh, Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Anjali |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
PG Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh
South West
DELHI |
7015087815
ANJALILANGYAIN08@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshurak Rasayana, Reference: Acharya Vagbhatt in Ashtang Hridaya Uttartantra “Rasyanavidhi Adhyayaâ€, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Godugdh), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritadi Kwath, Reference: Chakardatta in 32 Adhyaya Mutrakrichha Chikitsa Shlok Verse 2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with sign &symptoms of CKD of stage 1,2, 3a & 3b; with or without anemia as per standard KDIGO-CRITERIA.
2.Patient presenting with minimum 3 symptoms of Mutravaha Srotas Dusti along with symptoms of Pandu.
3.Patient having controlled DM2 FBS less than or equal to 130mg/dl, PPBS less than or equal to 200mg/dl, HbA1C less than 7% having CKD symptoms with or without HTN or DM2.
4.Age more than or equal to 25yrs and less than or equal to 65yrs.
5. Patient must be either male or female.
6.Subjects who are willing to sign the informed consent.
7.Subjects who are not registered in any other research project.
8. Patient having cause of chronic kidney disease either pre-renal causes or renal causes.
|
|
| ExclusionCriteria |
| Details |
1.Patient take insulin for blood glucose control or HbA1C is more than or equal to 7%.
2.Stage 4 HTN i.e. Patient has B.P.≥160/100mmHg with medication.
3.Patient undergoes Dialysis or any renal transplant.
4.Urinary-tract obstructions like Benign Prostatic Hypertrophy, Renal calculi tumours or diseases Such as HIV-patients, Hepatitis-B, Hepatitis-C.
5.Lactating Mothers and in pregnant females.
6.Patients suffering from major diseases- a. coronary artery diseases (CAD) b. Malignancy c. Chronic liver disease d. Ascites e. Tuberculosis f. Sexually transmitted disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in e-GFR which is determined through calculations based on laboratory reports. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce Sr. Creatinine, Serum Blood Urea,
Improvement in Sr. Electrolytes (Na+, K+, Ca2+, PO4, HCO3-),
Increase Hb%.
Reduce severity of Lakshan of Mutravaha Srotas Dusti:
Atisrishtam-atibaddamutram-alpa-alpa mutra- (Increase in frequency of urine-Anuria-Oliguria)
Bahalam Mutram - (Increase in volume of urine)
Muscle cramps, Anorexia, Generalized weakness, Fatigue.
Akshikuta-mukha-paade shavyathu (Facial - pedal Edema)
Raktalpata-pandutvam (Hemoglobinemia)
Alpamedata- (Weight loss)
|
30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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 Yet Recruiting |
| 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 is defined as the
presence of an abnormality in kidney structure or function persisting for more
than 3 months, with or without decreased GFR, manifest by either pathological
abnormalities or markers of kidney damage, including abnormalities in the
composition of the blood or urine, or abnormal imaging tests or GFR less than
60 mL/min/1.73 m2 with or without kidney damage. The worldwide prevalence of CKD (all stages) is
estimated to be between 8 to 16%, a figure that may indicate millions of deaths
annually. The overall prevalence of
CKD in SEEK INDIA cohort was observed to be 17.2% population Prevalence of CKD stage 1 is 7%, stage 2 is 4.3%, stage 3 is
4.3%, stage 4 and stage 5 is 0.8% respectively. Although there is no
description of CKD in Ayurveda Classics as per disease of MutravahaSrotas,
but disease described as per the manifestation from Hetu, Dosha, Dhatu,
Dushti, Lakshana, etc. In Ayurveda kidney is called Vrikka. Origin
of Vrikka is from Rakta and Meda dhatu. In Ayurveda,
toxins of urine is called Mala. According to Ayurvedic principle of
treatment, our aim is to treat Rakta, meda and mala. Hence, CKD is the
collaborative progression of Rasavaha, Raktavaha, Mamsavaha,
Medovaha-SrotasDusti which reflects through MutravahaSrotas
including Ojas Dusti.
In Ayurvedic context, Acharya Charaka stated
that basti (urinary bladder) and Vankashna ( groin) as Mula
of Mutravaha Srotas .Similarly, according to Acharya Sushruta ,urine formation occurs
in Pakvashayagat sthana which is secreted through Gavini’s(ureters)
and stored in Basti(urinary bladder). He also states that Basti regulates the Kleda (maintain
water-electrolyte Balance which is the function of Kidney) and collection of mutra. So, this manifests that
formation and excretion of Mutra is chain mechanism of Mutravaha
Srotas where functions of all organs related to one another, if there
is pathology arises in any part of Mutravaha
Srotas leads to Mutravaha Srotas Dusti.
The Lakshana of Mutravaha
Srotas Dusti, mentioned by Acharya Charak described as –
Atisrashtammutra
(Increase
in frequency of urine)
Alpa-Alpa
Abhikshnam (Oliguria)
AtivibadhamMutra (Anuria)
Bahalammutram (Increase in volume of urine)
Sashoolam Mutradrashtam (Dysuria)
Group A: Amritadi Kwath 40ml 2 times a day empty stomach in
morning,2hours before meal in evening
Group B: Gokshurak Rasayana 5gms, 2times a day after meals in morning and
evening
|