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CTRI Number  CTRI/2024/12/077827 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of Pathyaputhikadi kashaya and Kankayana gudika in patients with Uterine fibroid 
Scientific Title of Study   Effect of Pathyaputhikadi kashaya and Kankayana gudika in Uterine fibroid  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthika Dev S 
Designation  PG Scholar  
Affiliation  Government Ayurveda Medical College  
Address  Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam
Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Pin 682301
Ernakulam
KERALA
682301
India 
Phone  9446656617  
Fax    
Email  karthikadev.1993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajitha R Warriar  
Designation  Associate professor  
Affiliation  Government Ayurveda Medical College  
Address  Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam
Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam Pin 682301
Ernakulam
KERALA
682301
India 
Phone  9947144562  
Fax    
Email  drrajithawarriar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajitha R Warriar  
Designation  Associate professor  
Affiliation  Government Ayurveda Medical centre  
Address  Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam
Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam Pin 682301
Ernakulam
KERALA
682301
India 
Phone  9947144562  
Fax    
Email  drrajithawarriar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College, Tripunithura, Ernakulam pin 682301 
 
Primary Sponsor  
Name  Karthika Dev S 
Address  Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam pin 682301 
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 
Karthika Dev S  Government Ayurveda Medical College   Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam Pin 682301
Ernakulam
KERALA 
9446656617

karthikadev.1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee for Ethics in Research (Institutional Review Board ), Government Ayurveda Medical centre, Tripunithura, Ernakulam, pin 682301  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: GRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Pathyaputhikadi Kashaya , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Yava kshara, Hingu ), Additional Information: -Kashaya during intermenstrual phase
2Intervention ArmDrugClassical(1) Medicine Name: Kankayana gudika , Reference: Bhaishajya Ratnavali, Gulma chikitsa, 32 nd chapter, 68 th sloga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: Gudika only during bleeding phase
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Participants of age group 18-45 years with Uterine fibroids, confirmed by USG having complaints of pain and bleeding during menstruation  
 
ExclusionCriteria 
Details  Pregnant and lactating women
Post menopausal women
Hb less than 8 gm%
Fibroid size greater than 8 cm
Degenerative changes in the uterine fibroid confirmed by USG
Known cases of malignancy and genital Tb
Known case of uncontrolled Hypertension, Diabetes mellitus
Known cases of chronic liver and renal disease and coagulation disorders  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pain and bleeding during menstruation associated with Uterine fibroid   After 4 th week,8th week and 12th week  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pelvic pain and low back ache associated with Uterine fibroid
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in reducing the size of the fibroid  
After 1st,2nd and 3rd menstrual cycle  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 2/ Phase 3 
Date of First Enrollment (India)   18/12/2024 
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 Yet Recruiting 
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   Uterine fibroids also known as Leiomyomas, are smooth tumors of the These are more common in nulliparous or in those having one child infertility. Symptoms include abnormal uterine bleeding, dysmenorrhoea, pelvic pressure, bowel dysfunction , urinary frequency and urgency, urinary retention, low back pain, constipation and dyspareunia.
There is no direct reference for uterine fibroid in Ayurveda. The treatments explained in the context of Gulma and Sula can be taken for the management of uterine fibroid. Pathyaputhikadi kashaya is mentioned in Sahasrayogam with an indication of Arsa, Gulma, Ashteela, Anaha , Sula etc and Kankayana gudika is mentioned in Bhaishajya Ratnavali with an indication of Gulma,Arsa etc are taken for the study.
The study design is an interventional pre and post study, with a sample size of 26. Subjects aged 18 -45 years, diagnosed with Uterine fibroid having pain and bleeding following the inclusion and exclusion criteria will be taken for the study. Data collection will be done by clinical observation through case proforma and relevant investigations will also be done. The medicine will be administered on the following basis. 48 ml of Pathyaputhikadi kashaya before food during intermenstrual phase and 2 tablets (600 mg) of Kankayana gudika with 50 ml milk after food during the bleeding phase, twice daily for 3 consecutive menstrual cycle. The patient will be assessed at the end of each menstrual cycle. Menstrual bleeding is assessed by the Pictorial Blood Loss Assesment Chart (PBAC scale) and pain during menstruation, low back ache, pelvic pressure is assessed by Visual Analogue scale ( VAS). The size of the fibroid is assessed by USG before treatment and after treatment. The data collected will be statistically analysed through appropriate tests and a conclusion will be drawn. 
 
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