| CTRI Number |
CTRI/2024/07/069889 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional study to evaluate the effect of syrup mutra sangrahaneeya mahakashaya in participients of childhood nephrotic syndrome. |
|
Scientific Title of Study
|
A single arm open label interventional study to evaluate the efficacy of mutra sangrahaneeya mahakashaya in childhood nephrotic syndrome w.s.r. to ojo vyapada. |
| 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 Aisha Amrin Jahan Qadari |
| Designation |
PG Scholar |
| Affiliation |
National institute of ayurveda, JAIPUR |
| Address |
Department of Kaumarbhritya,
Room no. 222,
National Institute of Ayurveda, Deemed to be university, Amer road, jorawar singh gate, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9530262786 |
| Fax |
|
| Email |
aishaamrin1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shrinidhi Kumar K |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, JAIPUR |
| Address |
Department of Kaumarbhritya,
Room no. 222,
National Institute of Ayurveda, Deemed to be university, Amer road, jorawar singh gate, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aisha Amrin Jahan Qadari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, JAIPUR |
| Address |
Department of Kaumarbhritya,
Room no. 222,
National Institute of Ayurveda, Deemed to be university, Amer road, jorawar singh gate, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9530262786 |
| Fax |
|
| Email |
aishaamrin1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vice chancellor of National Institute Of Ayurveda, deemed to be university, Jaipur, pin code 302002 |
|
|
Primary Sponsor
|
| Name |
NO SPONSER |
| Address |
NO SPONSER |
| Type of Sponsor |
Other [NO SPONSER] |
|
|
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 Aisha Amrin Jahan Qadari |
National institute of ayurveda, jaipur |
dept of balaroga,opd no 5, amer road, jorawar singh gate, jaipur-302002 Jaipur RAJASTHAN |
9530262786
aishaamrin1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, NIA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N049||Nephrotic syndrome with unspecified morphologic changes. Ayurveda Condition: OJOVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: mutra sangrahaniya mahakashya, Reference: charaka sutrasthan, adhyaya 4, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of Minimal Change steroid dependent Nephrotic Syndrome with less than three relapses so far.
2.Diagnosed cases of Minimal Change Nephrotic Syndrome with less than nephrotic range of proteinurea (not more than 3gm/24 hr protein loss)
3.Diagnosed cases of Minimal Change Nephrotic Syndrome without any documented adverse effects of steroid therapy.
4.Diagnosed cases of Minimal Change Nephrotic Syndrome with chronicity of less than 1 year.
|
|
| ExclusionCriteria |
| Details |
1.Child with more than three episodes of recurrences requiring higher doses of steroid and with chronicity of more than one year and more than three relapses so far.
2.Children with gross Congenital Anomalies, urogenital anomalies
3.Children with Genetic Nephrotic Syndrome and involvement of kidney parenchyma
4.Children with Secondary Glomerulonephritis (eg. Post infectious Glomerulonephritis, SLE, Diabetic neuropathy, Henoch-Schonlein Syndrome)
5.Children of Nephrotic Syndrome with end stage disease.
6.Children receiving immune-suppressant other than steroid like cytotoxic drugs etc. with indication of renal biopsy
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Proteinurea in children with Minimal Change Nephrotic Syndrome |
at baseline,15th day, 30th day, 45th day, 60th day,75th dayand 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in biochemical parameters e.g., serum protein, serum cholesterol, serum creatinine
• Change in quality of life & general condition of children.
|
90th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/07/2024 |
| Date of Study Completion (India) |
04/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/10/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Childhood period witness maximum physical and psychological growth and development, hence ensuring the same against certain infections, nutritional, environmental and auto immune disorders is need of the hour as it adversely affects the future life of child. Healthy childhood period is a platform for future healthy life. Principles of Ayurveda are very unique due to its global approach with utmost importance to prevent the disorders rather than curing the disease. As the generation passed the human lifestyle has been deviated from normal principles of nature, resulting in numerous immunological and life style related disorders which are becoming very common in present day scenario. As per evidences the immunodeficiency, immuno suppressive and hyper immunity disorders are three major categories of immune disorders in children in recent days. Incidences of hyper immunity or immune exaggeration are on the upper surge in past few decades and emerged as burning problem in the present-day clinical practice and minimal change nephrotic syndrome is one among them, which is becoming more and more common in early pediatric age. Minimal change nephrotic syndrome is one of the common types of primary nephrotic syndrome (90%). The incidence of Nephrotic Syndrome (MCNS) is 2-7 patients in 100000 population per year and is equally found in both sexes, as per ISKDC (International Study of Kidney Diseases in Children)[i]. In India childhood nephrotic syndrome has an incidence of 90-100 per million population[ii]. It is characterized by symptom complex which include proteinurea, hypoalbuminemia and edema. The characteristic symptoms are heavy/ massive proteinurea (>3.5 gm /24 hrs in adults or 40mg/m2/hr in children), hypoalbuminemia (<2.9gm/dl), edema, hyperlipidemia(220mg/dl) with increased tendency for coagulation[iii]. According to International Study of Kidney Diseases in Children (ISKDC classification), this is an immunological disorder with affliction of glomeruli due to deposition of the immune complex leading to basement membrane and podocyte layer damage which further leads to increased albumin loss through glomerullar filtration. In the later part there will be hyalization and also loss of other constituents of the blood including RBC. In Minimal Change Nephrotic Syndrome, Renal biopsy does not show significant abnormalities in light microscopy. On the other hand, Focal Segmental glomerulonecrosis (FSGS) the other type of primary nephrotic syndrome shows evidence of sclerosis involving a segment of glomerular tuft. Minimal change nephrotic syndrome is known for its recurrency and relapse, especially after a viral infection due to immune exaggeration and with each recurrency disease become more and more chronic[iv]. This not only hampers the growth of the body but also functional capacity of child leading to psychological instability along with behavior and personality changes. School missing may lead to failure in academic performances. However, as the disease becomes chronic the complications of the disease and adverse effect of the medication totally debilitate the child. The series of complications of Nephrotic syndrome are like infections, thromboembolic disorders, acute kidney failure, pulmonary edema, protein malnutrition and growth retardation. Meanwhile continuous loss of protein, especially albumin through urine resulting in altered plasma oncotic pressure and leads to disturbance in fluid compartment and leads to progressive edema which is more evident in the periorbital area. Later edema spreads to dependent area, peritoneum, pleura and pericardium. However, Ayurveda understand above disease entity with immunological background and this can be included under different complications and sequels of Ojo Vyapada which includes symptom complex like Vaata Shopha, Stambdhagaatrataa, varnabheda, guru gaatrataa, glaani, tandra, nidra.[v] etc. [i] IAP, Text book of Pediatrics, Parthsarthy, 4th edition 2008, Jaypee Brothers Medical Publishers(P) Ltd, page no. 743 [ii] Kumar K, Sharma S. Gupta N.Prevalence of different clinical variants of Nephrotic Syndome in children 1-18 years of age in tertiary care hospital of north India, Int. J Sci Stud 2020;7(10): 121-124. [iii] Text book of nephrology, Anil K Mandal, Jaypee brothers medical publishers,ISBN 978-93-5090-532-6, page no. 350 [iv] Ghai Essential Pediatrics, by CBS Publishers & Distributors Pvt Ltd, 8th Edition 2017, page no. 479 [v]Sushruta Samhita with Nibandhasangraha commentary by Shri Dalhana Acharya, edited by Vaidya Yadavji Trikamji Acharya, Sutra sthaana chapter no. 15, shloka no. 24. |