Use of ayurvedic drug in the management of urinary infection.
- Conditions
- Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM,
- Registration Number
- CTRI/2023/08/056345
- Lead Sponsor
- Keshav ayurvedic medical college and hospital
- Brief Summary
**Randomised Control Study of *Ayurvedic* Formulation *(Madhukadighana Vati)* in the Management of *Mootrakrichchhra* (Urinary Tract Infection).**
**SYNOPSIS**
**Synopsis submitted to**
**The Faculty of Ayurveda**
**Dr. Sarvapalli Radhakrishnan Rajasthan Ayurved university Jodhpur**
**for the degree of**
***Ayurveda Vidhyavaridhi***
**[Ph.D.]**
**Speciality - Shalya Tantra**
**SCHOLAR**
**Geeta**
**SUPERVISOR**
**Prof. Rajesh Kumar Gupta**
**Department of Shalya Tantra**
University Post Graduate Institute of Ayurvedic Studies & Research, Jodhpur
Dr. S.R. Rajasthan Ayurved University, Jodhpur-342037
RAJASTHAN, INDIA
**Application of dissertation**
To
**The Registrar**,
**Dr. Sarvapalli Radhakrishnan**
**Rajasthan Ayurveda University**
**Jodhpur.**
**Subject:** Submission of the Plan of Dissertation for the award of “*Ayurveda Vidhyavaridhi-* [Ph.D. (*Ayu.)*] in the speciality of *shalya tantra*. (Through - Proper Channel)
**Respected Sir**,
With due regards, I am here by submitting the synopsis of my research project for the award of **“*Ayurveda Vidhyavaridhi- [Ph.D .(Ayu.)*] in the Speciality of *Shalya Tantra*** for your kind permission.
Name of Scholar : Dr. Geeta
Father’s Name : Shri Nanar Ram
Date of Birth : 12-08-1992
Permanent Address : Ward no.5, Todi Madhopura,
: Via-Ranoli,Teh-Sikar,
Dist-Sikar
State- Rajasthan, Pin-332403
Enrolment Number :
Pervious Examination : B.A.M.S,NIA,Jaipur(DSRRAU Jodhpur)
M.S. (Ayu) IMS, BHU, Varanasi, U.P.
Name of Department : Department of Shalya Tantra
Name of Institute : DSRRAU Jodhpur
Language of Thesis : English and Sanskrit
Title of Dissertation: **Randomised Control Study of *Ayurvedic* Formulation *(Madhukadighana Vati)* in the Management of *Mootrakrichchhra* (Urinary Tract Infection).**
**Researcher** **Supervisor**
Dr. Geeta Prof. Rajesh Kumar Gupta
**RESEARCH QUESTION:** Is “***Madhukaadighana Vatiâ€*** effective in the management of Urinary Tract Infection?
**HYPOTHESIS**
1. **Null Hypothesis (H0)-** There is no significant effect of ***Madhukaadighana Vati*** in the management of Urinary Tract Infection.
2. **Alternative Hypothesis (H1)-** There is significant effect of ***Madhukaadighana Vati*** in the management of Urinary Tract Infection.
**INTRODUCTION-**
An infection of the urinary system, which includes the kidneys, bladder, ureters, and urethra, is known as a urinary tract infection, or UTI. UTI is a bacterial invasion-induced inflammatory response of the urothelium that is typically accompanied by bacteriuria and pyuria. Bacteriuria is the presence of bacteria in ordinarily bacterial-free urine. White blood cells (WBCs) in the urine, known as pyuria, are typically a sign of infection and/or an inflammatory reaction of the urothelium to bacteria, stones, or other indwelling foreign bodies.[****[i]****](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn1)
Urinary tract infections (UTIs) are the most common persistent infections, with a lifetime incidence of 50�’60% in adult women. The occurrence of UTI rises with age, and in women aged over 65 is almost double the rate seen in the female population overall. In younger women, increased sexual activity is a chief risk factor for UTIs and reappearance within 6 months is common.[****[ii]****](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn2) Urinary tract infections are the most common bacterial infections in women.[****[iii]****](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn3)
They occur normally between the ages of 16 and 35 years, with 10% of women receiving an infection yearly and more than 40–60% having an infection at some stage in their lives.[****[iv]****](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn4) Recurrences are common, with nearly half of people getting a second infection within a year. Urinary tract infections occur four times more commonly in females than males.[****[v]****](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn5) Urinary tract infections (UTIs) are common, affect men and women of all ages, and vary intensely in their appearance and sequelae. They are a common cause of illness and can lead to significant impermanence. Although the urinary tract is normally free of bacterial growth, bacteria that usually ascend from the rectal region may cause UTIs. Bacterial inoculation, colonisation, and urinary tract infection happen when bacterial pathogenicity rises or host defence mechanisms weaken. Most infections are successfully resolved with careful diagnosis and treatment.
In *Ayurvedic* texts various *mootrarogas* and their management have described under the heading of *Ashmari, mootrakrichchhra* and *mutraghata*, although the symptom multifaceted of above diseases is seeming to be overlapping but *Acharyas* distinguish them on the basis of intensity of obstruction and intensity of pain, in *mootrakrichchhra* painful micturition occur.
*Dalhana* had explained *Mootraghat* - *Mootravarodha[**[vi]**](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn6)* (obstruction of urine).
The word *Mootrakrichchhra* means painful micturition.[[vii]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn7) Painful micturition (*Mootrakrichchhra*) is divided into 8 types (according to *sushruta)*-
*Vataj Pittaj Kaphaj Sanipataj Ashmarij Shakrit Sharkara Abhighataj*
*Vijayrakshit* in his commentary *Mudhukosh* on *Madhavnidan* cleared this controversy[[viii]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_edn8) Obstruction is the main feature of *Mootraghat* where dysuria is main feature of *Mootrakrichchhra.*
**REVIEW OF LITERATURE:**
Literature related to Ayurveda, including classics, commentaries, texts, research journals available in University library, online portals like PubMed Central, AYUSH research portal, and Google Scholar, will be collected and evaluated. The suitable method will be used for future studies based on the literature review.
**AIM AND OBJECTIVES-**
**Aim-**
To evaluate the clinical efficacy of *Ayurvedic* compound in the management of *Mootrakrichchhra* (Urinary Tract Infection).
**Primary** **objectives**
To analyse the *Mootrakrichchhra* on the basis of textual reference in *Brihatraye* as well as contemporary medical science.
**Secondary objectives**
1. To carry out the comprehensive literary study on *Mootrakrichchhra*.
2. To provide cheap, safe and effective treatment in UTI.
3. To standardize an Ayurvedic line of treatment which may prove effective in the management of the UTI.
**NEED OF THE STUDY-**
UTI is a challenging task for modern medical science as well as other system of medicine, it is more common in females rather than males, because urethral and anal verge get closer due to the shorter length of the female urethra.
As per modern medical science, most cases of UTI are treated by short term medical management viz- antibiotics are given after culture and sensitivity test but recurrence is occurred in many cases. Many studies have been conducted in modern medical science as well as in Ayurveda also, but no medication has been found effective to encounter this bourgeoning area.
In Ayurveda, *Uttar Basti* therapy has been found very effective to encounter UTI but the main problem associated with Uttara Basti is, patient feels more discomfort, hesitation and follow the strict aseptic precautions for administration of medication via urethral route, it takes long duration of treatment course with admission in Hospital under the observation of Ayurveda specialist.
At this time, in UTI, we need such medicine, which is effective in curing the disease, at the same time the patient should not have any problem in taking medicine and he does not have to be admitted in the hospital.
Hence considering above facts **“****Randomised Control Study of *Ayurvedic* Formulation *(Madhukadighana Vati)* in the Management of *Mootrakrichchhra* (Urinary Tract Infectionâ€)** we have been planned.
**MATERIALS AND METHODS**
**1.** **Literary materials:** **-**
There will be critical review of relevant literatures in *Ayurveda* and modern text books, previous research paper and different medical text books and journals.
**2.** **Clinical materials: -**
**Selection of the patient-**
For the clinical trial 100 Patients will be selected from the OPD and IPD of KAMCH, Aklera, Jhalawar, Rajasthan and University Post Graduate Institute of Ayurvedic Studies & Research, jodhpur.
**Base of selection of patients-**
**Inclusion criteria**-
1. Patients of *Mootrakrichchhra* according to classical sign and symptoms with positive urine microscopy and urine culture.
2. Age- 16 to 70 years (*Madhayma Ayu* according to *Acharya* *Sushruta-Su.Su*.35/35)
3. Sex- Both, male and female
**Exclusion criteria*****-***
1. Age- below 16 years and above 70 years patient.
2. Genital Herpes.
3. Cancer patients (like-vaginal, uterine, bladder).
4. Tuberculosis affecting the any part of urinary system like- Bladder TB.
5. Uncontrolled Diabetes Mellitus
6. Subjects with ARF and CRF
7. Subjects with Venereal Diseases
8. HIV & HBsAg and Anti-HIV positive subjects
9. Any associated bleeding disorder or sign of any severe illness
10. Patient suffering from diseases such as Hepatic, CVS, CNS, Respiratory and Haematological disorders.
**Withdrawal Criteria: -**
1. Patients developing any threatening complication during this trial. If any adverse effects are found, then it will be withdrawn from the study and informed to nearby Pharmacovigilance cell.
2. Patient not willing to continue treatment.
3. Any other acute illness.
**Selection of trial drugs:** **-** *Madhuka, Gokshura, Chandan.*
All three drugs are selected from *Mahakasaya Varga,* described by *Acharya Charaka* (*Cha. Sut*.4*)*
***Madhuka*** *– Jivaniya, Kandughna and Mutravirjaniya Mahakasaya.*
***Gokshura****- Karmighna, Mutravirechaniya and Sothahar Mahakasaya.*
***Chandan-*** *Kandughna, Vishaghna and Dahaprasamana Mahakasaya.*
***Ayurvedic*** **Formulation *(Madhukadighana Vati)-***
**Ingredients:-(According to API )**
| | | | | |
| --- | --- | --- | --- | --- |
|**S. No.**
***Sanskrita/ Hindi*** **name of Drugs**
**Latin name**
**Part used**
**Amount *(Matra)***
|**1**
*Madhuka/ Yasthimadhu/ Mulathi*
*Glycyrrhiza glabra Linn.*
Root
1 part
|**2**
*Gokshura*
*Tribulus terrestris Linn.*
fruit
1 part
|**3**
*Raktachandan*
*(Sha.Pur.1st Chep., Slok no. 50)*
*Pterocarpus santalinus* *Linn.*
*Kandsaar*
1 part
**Preparation of Medicine: -**
```
The drugs needed for the trial will be identified, collected according to classics. Then these drugs will be prepared in the form of Ghana Vati supplied to the patient. We will Prepare the Kawath according to Sharanghdhara method then cook the Kawath again on the fire and when the consistency of kawath is reach up to semisolid state, then it is dried and made up into a form of Ghana Vati. (Sha. Mad. 2/1-2), (Sha. Mad. 8/1, 3), (Ayu. Pra.3).
```
**Group-** Two groups
**Group allocation-**
**In Group A***:* -
For internal use – Tab. Levofloxacin 500 mg OD
No medicine will be used for external use*.*
**In Group B****: -**
For internal use -*Madhukadighana Vati*500 mg TDS
No medicine will be used for external use*.*
***Pathya-Apathya*****: -**Patient will be made to follow *Pathya-Apathya* while taking medication.
**PLAN OF STUDY**
**Clinical study**
Under direct supervision, clinical research will be conducted on patients while taking into consideration the inclusion and exclusion criteria.
**Study type**: Interventional
**Masking****:**open label
**Study design of clinical trial:**
The present study is supposed to be**-**
**1.** Open Label
**2.** Randomized-computer generated randomization
**3.** Interventional type
**4.** Comparative study.
**Sample size**100
**No. of group:** Two groups
**Duration of trial:**Duration of medication will be of 14 days or two weeks
**Follow up****:** every 15th day up to 60 days.
**Primary purpose:** Efficacy
**End point****:**Treatment and improved quality of life.
**Protocol of Clinical Study**
1. The patient’s consent after being informed of the benefits and drawbacks of the trial and its proposed duration.
2. Fulfilling inclusion requirements
3. The patients’ identification
4. Before the treatment, the patient will be informed about the preceding investigations.
5. The study’s planned Performa shall be referenced when discussing observations and outcomes.
6. Data will be statistically examined using statistical methods
**Criteria for assessment**
**(Symptoms of *Mootrakrichchhra* or U.T.I.)**
The effect of trial drug will be assessed in terms of Subjective and Objective parameters.
**Subjective parameters**: For subjective parameters following symptoms will be assessed
1. Frequent urination
2. Urgency
3. Dysuria
4. Burning micturition
5. Pain (Supra pubic region)
6. Haematuria
7. Fever & chills
**Objective parameters:**
**Investigations:** -To make diagnosis and achieving the response of drug, the following investigations will be conducted at the time of registration and after therapy i.e., follow up: -
1. Routine blood examination- TLC, DLC, Hb, ESR, PLT, Blood urea, Serum creatinine.
2. Random blood sugar.
3. Urine - Routine and Microscopy for reaction, appearance, albumin, sugar, RBC, pus cells, cast, epithelial cells, PH etc.
4. Urine – Culture and sensitivity for specific causative bacterial growth.
5. USG- abdomen (KUB, Prostate, PVRU, Bladder wall thickness)
**Statistical analysis**- Observation regarding in the changes in clinical symptoms and investigatory finding will be analysed after completion of study.
**Ethical considerations:**
This study will be conducted according to the prevalent standards of Good Clinical Practice. This protocol and any amendments will be submitted to Institutional Ethics Committee (IEC) for approval of the study conduct. Drugs used in this trial are apparently safe, there is no any side effect recorded previously. If any ADE (Adverse Drug Effects) recorded during trial then it will be informed to Ethical Committee and appropriate measures will be take.
**Previous researches and research articles**
**1**.Clinical and experimental studies on the management of *Mutrakrichhra* by Dr.P.G. Gupta:1974
**2**.Role of *Trivanga* in urinary tract infection: by Dr.Bhupendra Sharma:1974.
**3**.Role of *shilajatu* in various urinary disorders: by Dr.R.C.Pant:1977.
**4.**The management of *Mutrakrichhra* and *Mutraghata* in *Ayurveda*: by Dr. A.R.Giri:1981
**5**.Study of Bladder function under influence of *Varuna* : by Dr. P.Kumar:1981. **6**.Role of *Chandraprabha vati* in U.T.I.: by Dr.Kumari Mridula Singh:1984.
**7**.Study of *vasti karma* in *Mutra roga*:by Dr.V.K.Sharma:1986
**8.**An *Ayurvedic* approach of urinary disorder:by Dr. A.R.Acharya:1987
**9.**Studies on *vasti karma* in urinary disorder by imaging technique :by Dr. Manoj Pratap Singh: 1990.
10.Role of *Varun shigru ghan vatiin* management of U.T.I.: by Dr. M.K.Kureel:2006.
11.Study of urinary disorder in *Brihattriyee*:by Dr.Bishnu Kumar:2011.
12**.**Evidence based study of *Mootrakrichchhra* in female patients treated by *vasti chikitsa*:by Dr. Sharmila Tiwari:2015
13. To Evaluate the efficacy of *ayurvedic* compound with or without *Uttarbasti* in the management of *Mutrakriccha* w.s.r. to Urinary tract infection. (Dr. Ruchi 2019)
14. Evidance based study of *Mootrakriccha* in female patients treated by *Basti Chikitsa*, (Dr. Sarmila Tiwari, Ph.D. 2011)
---
**REFERENCES**
[i] Campbell-Walsh Urology Eleventh Edition- Volume One, Part III, Infections and Inflammation, 12 Infections of the Urinary Tract, 237
[[ii]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_ednref2) Medina M, Castillo-Pino E. An introduction to the epidemiology and burden of urinary tract infections. Ther Adv Urol. 2019 May 2; 11:1756287219832172. doi: 10.1177/1756287219832172. PMID: 31105774; PMCID: PMC6502976.
[[iii]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_ednref3) Colgan R, Williams M. Diagnosis and treatment of acute uncomplicated cystitis. Am Fam Physician. 2011 Oct 1;84(7):771-6. PMID: 22010614.
[[iv]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_ednref4) Salvatore S, Salvatore S, Cattoni E, Siesto G, Serati M, Sorice P, Torella M. Urinary tract infections in women. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):131-6. doi: 10.1016/j.ejogrb.2011.01.028. Epub 2011 Feb 23. PMID: 21349630.
[[v]](file:///C:/Users/DELL/Desktop/PhD.%20Matter/Ph.D%20synopsis.docx#_ednref5) Salvatore S, Salvatore S, Cattoni E, Siesto G, Serati M, Sorice P, Torella M. Urinary tract infections in women. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):131-6. doi: 10.1016/j.ejogrb.2011.01.028. Epub 2011 Feb 23. PMID: 21349630.
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**Consent form****/**सहमति – पतà¥à¤°
**About the study** **/** **शोध****के****विषय****में** **-**
This is a research work entitled “**Randomised Control Study of *Ayurvedic* Formulation *(Madhukadighana Vati)* in the Management of *Mootrakrichchhra* (Urinary Tract Infectionâ€).**
will be carried out in the Dr. Sarvapalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur.
Your participation in this study is voluntary. You may refuse to participate or withdraw from the study without affecting any medical treatment that you are receiving. If you agree to participate in this study, we will collect relevant information from you/your hospital records.
Data from the study will be used for research purpose only. There will be no direct benefit to you other than the satisfaction of participating in this research for the possible benefit of future generations. The results of the study may be helpful in improving the treatment which could benefited to future generation of patients. Your participation will give us insights into the problems faced by patients like you and will help us in improving our services. The information concerning your participation in the study will be kept confidential to the full extent permitted by law and used only for scientific purpose.
यह अधà¥à¤¯à¤¯à¤¨ Dr. Sarvapalli Radhakrishnan Rajasthan Ayurved University, Jodhpur में जà¥à¤žà¤¾à¤¤ करने के लिठहै **|** इस अधà¥à¤¯à¤¯à¤¨ में आपकी à¤à¤¾à¤—ीदारी आपकी सà¥à¤µà¤¾à¤¯à¤¤à¥à¤¤à¤¤à¤¾ पर निरà¥à¤à¤° है **|** आप इस अधà¥à¤¯à¤¯à¤¨ में à¤à¤¾à¤— लेने से कà¤à¥€ à¤à¥€ मना कर सकते है**,** इससे आपको मिलने वाले इलाज पर कोई पà¥à¤°à¤à¤¾à¤µ नहीं पड़ेगा **|** अगर आप इस अधà¥à¤¯à¤¯à¤¨ में अपनी à¤à¤¾à¤—ीदारी से सहमत है तो आपसे/आपके हॉसà¥à¤ªà¤¿à¤Ÿà¤² रिकॉरà¥à¤¡ से आवशà¥à¤¯à¤• आंकड़े à¤à¤•à¤¤à¥à¤° किये जायेंगे **|**
इस अधà¥à¤¯à¤¯à¤¨ से मिलने वाले तथà¥à¤¯à¥‹à¤‚ को अनà¥à¤¸à¤‚धान के लिठइसà¥à¤¤à¥‡à¤®à¤¾à¤² किया जायेगा **|** अनà¥à¤¸à¤‚धान के परिणाम से आने वाली पीढियों को लाठमिलेगा और हमें आपके जैसी बीमारी से गà¥à¤°à¤¸à¤¿à¤¤ रोगियों के इलाज को बेहतर करने में सहायता मिलेगी **|** आपकी à¤à¤¾à¤—ीदारी से समà¥à¤¬à¤‚धित तथà¥à¤¯à¥‹à¤‚ को पूरà¥à¤£à¤¤à¤ƒ नियमानà¥à¤¸à¤¾à¤° गà¥à¤ªà¥à¤¤ रखा जायेगा और केवल अनà¥à¤¸à¤‚धान के लिठपà¥à¤°à¤¯à¥‹à¤— किया जायेगा **|**
**Consent** **/** **सहमति****-**
I have read the explanation completely & I hereby give my consent to take part in the study.
मैंने पूरी तरह से अनà¥à¤¸à¤‚धान के विवरण को पॠलिया है और इसमें à¤à¤¾à¤—ीदारी के लिठसहमत हूठ**|**
**STATEMENT OF CONSENT**
I have discussed this study with to my satisfaction. I understood that my participation is voluntary and that I can withdraw from the study at any time without prejudice. I have read and agree to enter this research study, signing this form does not waive any of my legal rights.
I have informed that if I believe that I have some problem as a result of participating in the research study; I may contact the supervisor of this research study, Prof. Rajesh Gupta sir**.** I can review the matter and identify the medical resources which may be available to me.
Signature of Parent/Guardian
Signature of Resident
Signature of Supervisor
**Proposed contents of dissertation**
**Title****-** “**Randomised Control Study of *Ayurvedic* Formulation *(Madhukadighana Vati)* in the Management of *Mootrakrichchhra* (Urinary Tract Infectionâ€).**
All the observations recorded and results obtained will be computed statistically to draw various conclusions. The project will be presented in the form of a thesis with following contents-
1. Introduction
2. Review of literature
§ *Ayurvedic* review
§ Modern review
§ Drug review
3. Materials and Methods
4. Observations and Results
5. Discussions
6. Conclusion
7. Summary
8. References and Bibliography
9. Abbreviations
10.Appendix
§ Case history sheet Performa
§ List of patients
§ Consent form/ सहमति – पतà¥à¤°
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
- 1.Patients of Mootrakrichchhra according to classical sign and symptoms with positive urine microscopy and urine culture.
- 2.Age- 16 to 70 years (Madhayma Ayu according to Acharya Sushruta-Su.Su.35/35) 3.Sex- Both, male and female.
- 1.Age- below 16 years and above 70 years patient.
- 2.Genital Herpes.
- 3.Cancer patients (like-vaginal, uterine, bladder).
- 4.Tuberculosis affecting the any part of urinary system like- Bladder TB.
- 5.Uncontrolled Diabetes Mellitus 6.Subjects with ARF and CRF 7.Subjects with Venereal Diseases 8.HIV & HBsAg and Anti-HIV positive subjects 9.Any associated bleeding disorder or sign of any severe illness 10.Patient suffering from diseases such as Hepatic, CVS, CNS, Respiratory and Haematological disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical efficacy of ayurvedic compound in the management of mootrakrichchhra (Urinary Tract Infection). Every 15th day from the baseline up to 60 days
- Secondary Outcome Measures
Name Time Method Primary objectives To analyse the mootrakrichchhra on the basis of textual reference in brihatraye as well as contemporary medical science.
Trial Locations
- Locations (1)
Keshav ayurvedic medical college and hospital, Aklera
🇮🇳Jhalawar, RAJASTHAN, India
Keshav ayurvedic medical college and hospital, Aklera🇮🇳Jhalawar, RAJASTHAN, IndiaDr GeetaPrincipal investigator9120390109jalindrageeta@gmail.com