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CTRI Number  CTRI/2025/05/086567 [Registered on: 08/05/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Trial To Study the Effect of Kantakari Churna in the Management of Mutrakruchra with Special Reference to Acute Cystitis. 
Scientific Title of Study   A Randomized Clinical Controlled Trial To Study the Effect of Kantakari Churna in the Management of Mutrakruchra with Special Reference to Acute Cystitis. 
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 Harshada Rajesh Dholwade 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Nashik Maharashtra India 422403

Nashik
MAHARASHTRA
422403
India 
Phone  8530588537  
Fax    
Email  harshadadholwade@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa Premchand Badhe 
Designation  Professor 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Nashik Maharashtra 422403

Nashik
MAHARASHTRA
422403
India 
Phone  9689339928  
Fax    
Email  adkpc74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshada Rajesh Dholwade 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Nashik Maharashtra 422403

Nashik
MAHARASHTRA
422403
India 
Phone  8530588537  
Fax    
Email  harshadadholwade@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik Nashik MAHARASHTRA 422403 India 
 
Primary Sponsor  
Name  Dr Harshada Rajesh Dholwade 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik Nashik MAHARASHTRA 422403 India 
Type of Sponsor  Other [Self] 
 
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 Harshada Rajesh Dholwade  SMBT Ayurved College And Hospital  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Nashik Maharashtra 422403
Nashik
MAHARASHTRA 
08530588537

harshadadholwade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N300||Acute cystitis. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kantakari, Reference: Kaiyadev Nighantu (1/55), Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: -
2Comparator Arm (Non Ayurveda)-Nitrofurantoin100 mg 1 Tablet BID for 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients with classical symptoms of mutrakruchha.
2. Ages between 18 to 50 yrs. Both sexes .
3. Patient will be included irrespective of gender, religion, socio-economic status.
4. Patient with symptoms burning micturition, painful urination, frequency,urgency, suprapubic pain
 
 
ExclusionCriteria 
Details  1 Patients above age of 50 yrs. and below 18 yrs.
2 Patients having any type of surgery of urinary tract and medical disease of urinary system,Severe Haematuria,cathetarised patient, acute and chronic renal failure
3 Patients who are suffering with any other systemic disorders like Koch’s, cancer, BPH, Hiv ,Hbsag positive
4 pregnant women and lactating women
5 k/c/o DM,HTN, IHD ,TB , Mentally ill patient
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in sign and symtoms of Mutrakruchra according to Acute Cystitis Symptom Score Scale within 5days of treatment  5 Days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 
Date of First Enrollment (India)   19/05/2025 
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="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  
Ayurveda is comprehensive scientific system of medicine developed though ancient wisdom, clinical experience and experimentation. Ayurvedic classical texts like Bruhattrayee and Laghutrayee have widely described Mutrakruchha. The term Mutrakruchha comes under the disorders of Mutravaha Srotas, description of this disease is mentioned in almost all classical texts which reflects its prevalence in the ancient period. It is a disease involving basti marma. As basti is one among the Trimarma, it has great therapeutic importance
Difficulty in voiding of urine is known as mutrakruchha. The Mutravaha srotas maintains haemostasis of fluids in the body, it also detoxifies the body by eliminating certain waste products through Mutra which is formed in Pakvashaygat Sthana and stored in Basti. Mutra is an outcome product of digestion of food and metabolism in the body.A healthy urinary tract is generally resistant to infections. However, for anatomical reasons female lower urinary tract is more susceptible. Predisposing factors include female sex, poor hygienic conditions, environment, poverty and illiteracy also contribute to increasing percentage of urinary tract infections. Bacteria are by far the most common invading organisms. In Mutrakruchha , the word mutra itself mean urine and kruchh that is pain and difficulty while urinating and is main complaint of patient.
A urinary tract infection (UTI) is an infection that affects part of the urinary tract.When it affects the lower urinary tract it is known as a bladder infection (cystitis). The Mutrakruchha is closely related with acute cystitis. 
            Infection of the bladder gives rise to symptoms of frequency, urgency, suprapubic discomfort, dysuria and cloudy offensive urine. These symptoms are often known as ‘cystitis Nowadays, due to modern lifestyle and busy schedules people more often have to depend on food which lack hygiene, nutrients and are harmful for the health. The normal urge to micturate and defecate are avoided due to fast and busy lifestyle. Suppression of these urges leads to Vegavrodh. Although, Acute Cystitis is a benign condition, recurrent episodes are associated with reduction in quality of life, a negative impact on everyday activity and working ability, disturbances in sexual life, etc. which are troublesome for patients. 

The prevalence of cystitis  was found to be 30%  in india. 
Kantakari churna is selected as  it is  VataKaphghna, in its Doshaghnata, it is helpful for Shaman of associated Doshas taking part in etiopathogenesis of Moortakrichhra.

Ruksha, Laghu, Tikshna properties of Kantakari choorna reduces the chances of nidus formation as well as reduces the growth of infection by inhibiting the binding property of Kaphadosha.
      -    Aqueous and methanol extract of     solanum xantocarpum showed high antimicrobial activity against the E. Coli which is responsible for Urinary tract infection which plays major role in pathogenesis of Cystitis.
      -    Analgesic and anti inflammatory property of Kantakari helps to reduce pain in abdomen associated with Cystitis.
     -     Katu and Tiktarasa of Katakari helps in diminishing the ‘Kleda’ at Basti, ultimately preventing the growth of infection at Bastipradesh.
      -    Due to Ruksha guna of Kantakari, frequency of the Urine also get decreased.
  -     Thus, action of Kantakari choorna may ultimately result in reducing burning micturition, pain in abdomen associated with Cystitis due to their anti-inflammatory action. 
  -    Due to  SOLASODINE[15] it possess steroidal activity which reduces pain and due to  Campestrol it contains alkaloids which act on gram +ve and  gram ve bacteria.  
  -   Courmarin does the destruction of bacterial cell wall led to bacterial death.

Patients within Ages between 18 to 50 yrs. Both sexes were taken  
Along with the patients fulfillng  criteria of  classical symptoms of mutrakruchha as mentioned in the text are selected irrespective of sex, socio-economic status, and community, written consent from patient will be taken prior to study. Computerised generated Sampling technique will be used. Total
70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group). Kantakari Choorna Group A (trial group) with dose 2gm bd & anupana – koshna jaal and Nitrofurantoin Group B(Control group) 1tab twice day 100mg orally will be given to
patients. Both drugs will be administered in  for 5 days. Observations will be done on day 1,3,5 and 7th day.Result of study will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. 
Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
 
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