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CTRI Number  CTRI/2024/05/067544 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 11/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A Clinical Study Of Mootrakrichhaghni Peya And Yogasana In Mootrakrichha specially in U.T.I. 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF MOOTRAKRICHHAGHNI PEYA AND YOGASANA IN MOOTRAKRICHHA W.S.R. TO U.T.I. 
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 ANITA SHARMA 
Designation  Professor & H.O.D.  
Affiliation  SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGA 
Address  Room no. 06 Swasthvritta & yoga Department SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGARH

Raipur
CHHATTISGARH
492010
India 
Phone  9827115211  
Fax    
Email  ansharma260@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANITA SHARMA 
Designation  Professor & H.O.D. 
Affiliation  SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGA 
Address  Room no. 06 Swasthvritta & yoga Department SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGARH

Raipur
CHHATTISGARH
492010
India 
Phone  9827115211  
Fax    
Email  ansharma260@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ARUNA OJHA 
Designation  Professor & H.O.D. 
Affiliation  SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGARH 
Address  Room no. 02 Kayachikitsa Department SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGARH

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthvritta and Yoga Shri Narayan Prasad Awasthi Goverment Ayurvedic College Raipur Chhattisgarh 
 
Primary Sponsor  
Name  SHRI NPA GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGARH 
Address  SHRI N.P.A. GOVERMENT AYURVEDIC COLLEGE RAIPUR CHHATTISGA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogita Sharma  Shri Narayan Prasad Awasthi Goverment Ayurvedic College And Hospital Raipur  Room No.06 Swasthavritta & Yoga Department Room No. 02 kayachikitsa department Room no. 15 Prasooti tantra department
Raipur
CHHATTISGARH 
8839030641

yogitasharma216@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N000||Acute nephritic syndrome with minor glomerular abnormality. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: mootrakrichhaghni peya, Reference: charak sutra 2/22, Route: Oral, Dosage Form: Tandulodaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: mootrakrichhaghni peya and yogasana, Reference: chrak sutra 2/22 , hathyoga pradipika, Route: Oral, Dosage Form: Tandulodaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)The patient above 18-70 years of age irrespective of their gender, cast religion, occupation
& financial status.
2) Patient having symptoms described in Ayurveda & Modern Literature for
Mootrakrichha.
3) Patient willing for the Study.
4) Patient who had no serious organic or metabolic Aliments.  
 
ExclusionCriteria 
Details  1) Patient below 18 years and above 70 years of age.
2) Patients having any type of cancer associated with urinary bladder, kidney and pancreas
or any obstructive uropathy and diabetic patients will be excluded from study.
3) Pregnant and lactating women.
4) Patients who are unable to do these Yogasana. Patients with Poorly functioning kidney.
5) Patients not willing for the Study.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DYSURIA
SUPRAPUBIC PAIN
Pain in urinary Bladder
SENSATION OF INCOMPLETE BLADDER
EMPTYING DUE TO SPASM OF
INFLAMED BLADDER Wall MUHURMOOTRATA ALPAMOOTRATA
INCREASED
FREQUENCY
URINATION 
first follow up after 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement will be assesed on the basis o relief found in cardinal symptoms of based on the standard will be applied before & after treatment.
symtoms will be reduced.
mild dysuria,bladder pain will be mild,infection will be decrese. 
first follow up after 7 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 3/ Phase 4 
Date of First Enrollment (India)   23/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   INTRODUCTION - 

 â€œHealth is wealth” health is not nearly the absence of disease ,but is a positive quality of living body. Ayurveda is science of life ,considered to be an “Upaveda of Atharva veda”.In whom,the Dosas,Agni(digestive power),Dhatus(tissues),Malas(waste products) and the activities are normal; his soul, sense organs and mind are calm/clear is called “SVASTHA”[1](Healthy person). Dosha,Dhatu,Mala are the basic substratum of the Shareera. Mala being one among them & Mootra is one among the Trimala.Trimarmas (Vital parts) described by Ayurveda classics, Basti (Bladder) is one of them. known as best Pranayatan.The Mula of Mutravaha Strotas are-Basti and Vankshana.(Ch.Vi.5/8),Basti and Medhra.(Su.Sha.9/12)  It is derived from two words Mootra(urine), Krichha(Pain),so The disease in which Mutra is voided with much Dukha (discomfort) is called Mutrakrichha.The Pratyatma Lakshana of Mutrakrichha is “Dukhena Mutra Pravritti” means discomfort during Micturition.[4] 
                                                              In this disease patient has urge to micturate,but he passes urine with pain. It is being co related to dysuria.In Mootrakrichha vitiated Dosas along with Vata(mainly Apan Vayu) on reaching Basti(bladder)afflicts the Mootravaha Strotas and press upon the urinary passage. Then the person urinates with difficulty,with the symptoms like Daha,Ruja,Basti Gurutva ,Shotha, Muhurmutrata, Peet Mutrata,Sarakta Mutrata. The above mentioned symptomatology resemble more closely to symptoms of UTI.[5] Definition of Urinary tract infection is an infection that affects part the urinary tract. When it affects the lower urinary tract it is known as bladder infection (cystitis) and when it affects the upper urinary tract it is known as kidney infection (pyelonephritis).[6] Symptoms from a lower urinary tract include pain with urination, frequent urination etc. Usually enteric gram negative rods that have migrated to the urinary tract. The organisms involved in the infection are E.Coli & staphylosaprophyticus.Proteus mirabilis and Klebseilla Pneumoniae are rare causes.[7] 
                                                            “Aahara”is considered as MAHABHAISHAJYA. In ayurveda following healthy diet and dietic rules helps in protecting health and curing disease. Peya is one of them explained in ayurveda classics. “  “Peya” is gruel with boiled grains. ” Gokshura and Kantakari along with Phanita should be prescribed in dysuria.It produces sweating ,kindles, digestion, easily digestible, cleanses the urinary bladder, relieves hunger, thirst, fatigue and exhaustion and helps eliminate urine, flatus, faeces etc.[10] 
                                                             The science of yoga applies to all aspect of life. In Hathayoga Pradipika “MOOLABANDHA” explained as it moves the Apana vayu in upword direction.[11] It stimulates the pelvic nerves and tones the uro-genital and excretory systems. “SARVANGASANA” is beneficial in urinary disorders [12], uterine problems.it relaxes the nerves. ARDHA MATSYENDRASAN is benificial in Urinary tract diseases.(13) “SUPTAVAJRASAN” is relieves related to urinary bladder disease.[14]

 
NEED OF STUDY-

Good urinary habits are important for a healthy life. The overall prevalence of UTI was found to be 33.54%. Total 584 urine samples showed the significant bacterial growth 194(33.22%) samples from males and 390 (66.78) from female patients. [15] History of recent episode of UTI was observed as the commonest risk factor followed by diabetes mellitus. Altogether, 86 % of toal cases were caused by Escherichia coli (68 %) and Klebsiella pneumoniae (17.6 %) together. For the management of U.T.I. Analgesics, Antibiotics therapy used in modern medicine, but it may leads Renal damage, Gastric irrigation also. Recurrent UTI occurs, Antibiotics costly so we need cost effective management with easily available drug. No previous works done on the efficacy of Mootrakrichhaghni Peya & Yogasan in Mootrakrichha w.s.r. to UTI, so we decided to work on such ayurvedic formulation to find out their efficacy. “Peya” is gruel with boiled grains, produce diagestion, cleaness urinary bladder. In this Mootrakrichhaghni Peya, Gokshura and Kantakari are the Aushadh Dravyas.which are Mootral in property, so Mootrakrichhaghni Peya & Yogasan taken to compare action in mootrakrichha.
 
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