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CTRI Number  CTRI/2024/03/064705 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A clinical study of Mutravirechaneeya mahakashaya and Eladi kwath in the management of urolithiasis 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Mutravirechaneeya mahakashaya and Eladi kwath in the management of mutrashmari w.s.r. to urolithiasis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Aklesh@95  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aklesh 
Designation  PG SCHOLAR 
Affiliation   
Address  OPD NO. 2 & 18 Department of Kayachikitsa Shri NPA Govt. Ayurveda College, Raipur, C.G., India

Raipur
CHHATTISGARH
492010
India 
Phone  7974059943  
Fax    
Email  vermaaklesh777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Aruna ojha  
Designation  professor & HOD, Department of Kayachikitsa 
Affiliation   
Address  Department of Kayachikitsa Shri NPA Govt Ayurveda College, Raipur, C.G., India

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Rashmi diwan 
Designation  Lecturer, Department of Kayachikitsa 
Affiliation   
Address  Department of Kayachikitsa Shri NPA Govt Ayurveda College, Raipur, C.G., India

Raipur
CHHATTISGARH
492010
India 
Phone  9770933579  
Fax    
Email  rashmi.diwan3@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa, Shri NPA Govt. Ayurveda College, Raipur, C.G., India Pin- 492010 
 
Primary Sponsor  
Name  Department of Kayachikitsa,Shri NPA Govt. ayurved college raipur,c.g. 
Address  OPD No. 2 @ 18 Department of Kayachikitsa,Shri NPA Govt. ayurved college raipur,c.g. 
Type of Sponsor  Other [Govt. ayurved college raipur,c.g.] 
 
Details of Secondary Sponsor  
Name  Address 
Shri NPA Govt ayurved college raipurcg  Shri NPA Govt. ayurved college raipur,c.g. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AKLESH  OPD NO. 2&18,IPD DEPARTMENT OF KAYACHIKITSA  Shri NPA Govt. ayurved college raipur,c.g.
Raipur
CHHATTISGARH 
7974059943

vermaaklesh777@gmail.c0m 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Eladi kwath   Refrence - chakradatta Route - oral form - kwatha in from does-50 ml Frequency - morning and evening (BD) before meal Bhaisajya kaal - Pragbhakt Duration - 60 Days anupana - no 
Intervention  Mutravirechaneeya mahakashaya   Refrence - charak samhita Route - oral form - kwatha in from does-50 ml Frequency - morning and evening (BD) before meal Bhaisajya kaal - Pragbhakt Duration - 60 Days anupana - no 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age - 18 to 70 years
2.Gender-Both men and women (without discrimination of religion or caste)
3.On the basis of symptoms described in Ayurveda codes and modern texts.
4.Size of ashmari(stone-KUB). Ashmari(stone-KUB) of size 10mm or smaller without considering the number as basis. 
 
ExclusionCriteria 
Details  1. Below 18 years and above 70 years.
2. Pregnant and lactating women.
3. HIV and HBsAg infection.
4. Pyelonephritis, Glomerulonephritis, Obstructive uropathy, High creatinine.
5. Stag horn renal stone.
6. Uncontrolled DM, HTN.
7. Hepatic dysfunction.
8. Patients required surgical intervention.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce the symptoms of ashmari and minimize the size of stone-KUB  reduce the symptoms of ashmari and minimize the size of stone-KUB 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life  90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/05/2024 
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="0"
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  

Purpose of ayurveda

 To maintain the health of a healthy person.

 To cure the diseases of patient.

In this, to fulfill the first purpose, daily routine, seasonal routine, night routine and diet. There is a description of adherence to apathya and use of chemicals and to achieve the second purpose, there is a description of the three sutras and the quadruples of treatment.

 

In Ayurveda, Ashmari disease is one of the eight diseases.

 

vatvyadhi, prameha, kustha, arsha, bhagandar, ashmari, mudhagarbha, these seven and eighth udergat disease, these eight are major diseases and are harmful by nature.

 Ashmari is made up of two words, Ashm and Ari, Ashm means stone and Ari means enemy.

 

 

 

 

 12% of the world’s population is suffering from kidney stone disease, the recurrence rate of which is 70% to 81% in men and 47% to 60% in women.

97: Ashmari is found in kidney and ureter while the other 3: are found in urinary bladder and urethra.

Ashmari is a worldwide problem. Ashmari causes severe abdominal pain, burning sensation in urine, bloody urine and difficulty in urination.

   

Ashmari is a terrible disease, it should be considered equal to Yamraj (deadly). For new cancer, medical treatment is possible, but for old cancer, there is a need for weapon treatment.

Ashmari is a serious and painful disease, since Acharya Sushruta has called new asthma treatable, hence asthma should be treated in the new stage itself, so that the disease remains treatable.

 

Since the Samhita period, many Ayurvedic remedies are being used for the treatment of ashmari.

In the Samhita, Ashmari has been described under mutravaha shrotas. Which Tridoshaj is mainly Vatakafaj, which Acharya Charak has described under Samanjay Vikar.

Synonyms of Ashmari. stone, sarkara

Due to not correcting the body through vomiting, purging etc. and bad habits like wrong diet and behavior, the mucus which gets irritated by mixing with urine and enters the body, produces ashmari.

In the initial form of Ashmari, the symptoms are pain in the internal Urethral Orifice, loss of interest in food, dysuria, fever due to dysuria, and smell of goat in the urine.

 

Just as even when a new pitcher is filled with very clean water, after some time, sludge gets collected in the form of a precipitate, in the same way, in the existing clean urine too, stone formation occurs after some time.

 

When the air dries up the urine along with the semen or the phlegm along with the bile which has entered the urinary bladder, then the body becomes stoney, just like gorochan is formed in the gall bladder of a cow.

 

Form of Ashmari: Due to Vata dosha it is like Kadamba flower and Triputi is triangular, due to Pitta dosha it is hard and smooth like a stone and due to Kapha and Shukra it is soft.

 

Symptoms of kidney stone: When stone comes into the urinary tract, it blocks the passage and creates obstruction in urine output and causes pain in the colon. Then the urethra (from the root of the scrotum to the anus) causes pain in the penis and urinary bladder and produces many streams of urine and the patient urinates repeatedly.                                                        

                                                                          UROLITHIASIS

DEFINITION

          Stones is the urinary tract occur when urinary chemistry result in concentrations of stone salts that exceeds the limit of metastability for that salt in solution.

This most often reflects excessive excreation of one or more stone constituents,deficient inhibitory activity in urine, or simply a low urine volume resulting in excessively concentrated urine.

                                      

Ø PATHOPHYSIOLOGY

          Urinary calculi consist of aggregates of cristals ,usually containing calcium or phosphate  in combination with small amounts of proteins and glycoproteins. In devloped countries, however,most calculi occure in healthy young man, in whom investigation reveal no clear predesposing cause. Renal stone vary greatly in size. There may be particals like sand anywhare in the urinary tract, or large round stones are common, particularly in children.In developed countries,the incidence of childhood bladder stones is low,renal stones in  adults are more common.

Ø CAUSES

·        Low urine volumes, low fluid intake

·        Diet: high protien, high sodium, low calcium

·        High sodium, oxalate, urate excreation

·        Low citrate excretion

·        Renal tubular acidosis type1

·        Famillial hypercalciuria

 

v TYPES OF UROLITHIASIS

               1.Calcium 0xalate stones ( > 70%)

2.Uric acid stones (10%)

3.Struvite stones (15%)

4.Cystine stones (1%)

 

 

v SYMPTOMS

 

1.     Pain – (a) Ureteric colic – cramping, sharp, often excruciating pain,fluctuating in intensity but not completely remitting.

 

(b) Loin  pain  - independent of ureteric colicor infection.

    2. Haematuria – accompanying the colic or even frank haematuria in absence of colic.

v SIGNS

 

1.     Loin tenderness – is usually manifestation of associated infection.

 

2.     Palpable kidney in the presence of staghorn calculus, or when obstruction has remitted.

 

BASIS OF DRUG SELECTION:-

 The medicine for Asthmari has been described in detail in the scriptures, the selected combination of the medicine is effective in dissolving, eliminating and treating Asthmari, the component of urine-purifying Mahakashaya and Eladi Kwath, and is effective in preventing the recurrence of the disease.

 

 Use of castor oil as a supplement reduces the friction caused by emetic, emphysema and diaphoretic expulsion.

 All the components of the selected yoga are easily available and accessible at low cost.

 Aushadha yoga will be used in the form of kashay kalpana. Due to which it is immediately effective due to its quick absorption. Therefore, I have selected Mahakashay and Eladi Kwath, which is a diuretic and has castor oil as a Kashay.

 

 

 

 

 

 

 

 

 

  Before manufacturing the medicine, the medicine will be identified and tested by dravyaguna departmentof the college and NIScPIR new delhi .

 manufacureing of drugs will be done under the guidance of teachers of the rasasastra and bhaishgya kalpana Department of the college.

 

 After studying the data obtained, a report was prepared for analysis.

For clinical  subjective criteria – wilcoxon rank sum test

For clinical  objective criteria – paired t test

For comparative   subjective criteria – Mann whitney u test

For comparative  objective criteria – independent sample test will be used.

 

 


 
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