| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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 -
“Health 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 vedaâ€.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 “SVASTHAâ€[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] “Aaharaâ€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. |