1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [jalindrageeta@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-12-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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 Vati” 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]

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] Urinary tract infections are the most common bacterial infections in women.[iii]

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] 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] 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] (obstruction of urine).

The word Mootrakrichchhra means painful micturition.[vii] 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]  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 Infection”) 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 )

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 15^th 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)