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CTRI Number  CTRI/2021/11/038061 [Registered on: 15/11/2021] Trial Registered Prospectively
Last Modified On: 13/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF KANKAYAN VATI & ERANDMUL TAILAM BASTI ON IRREGULAR Periods 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KAANKAYAN VATI AND ERANDMUL TAILAM ANUVASANA BASTI ON POLY CYSTIC OVARIAN SYNDROME (PCOS) 
Trial Acronym  PCOS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pushp Kanwar 
Designation  PG Scholar 
Affiliation  madan mohan malviya govt ayurved college udaipur 
Address  PG Dept. of Prasuti Tantra evum Stri roga vibhag , madan mohan malviya govt.ayurved college udaipur rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  8005585973  
Fax    
Email  pushpkanwar23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mahesh Dixit 
Designation  Principal & Guide 
Affiliation  Madan mohan malviya ayurveda college 
Address  Madan mohan malviya ayurveda college campus amba mata, udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Mahesh Dixit 
Designation  Principal & Guide 
Affiliation  Madan mohan malviya ayurveda college 
Address  Madan mohan malviya ayurveda college campus amba mata, udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Source of Monetary or Material Support  
Madan mohan malviya ayurveda college,Udaipur 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College,rada ji circle Ambamata Udaipur 
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 
prof mahesh dixit  Madan mohan malviya ayurveda college,Udaipur  O.P.D Room no.5 P.G.department of prasuti tantra evum stri roga
Udaipur
RAJASTHAN 		 9414245459

prof.maheshdixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTINAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N914||Secondary oligomenorrhea. Ayurveda Condition: Disturbance of menstrual cycle,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kaankayan vati, Reference: Bhaishajya Ratnavali 39/56-62, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm), Additional Information:
2Comparator ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: charak sutra sthan 25/40, Procedure details: 25-40 ml per rectum 5 alternate days of menstrual cycles)
(1) Medicine Name: kaankayan vati, Reference: Bhaishajya Ratnavali 39/56-62, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patient who willing for the trial age group between 18 years to 40 years with irregular menstrual cycle scanty due to anovulatory cycle.
3. Poly Cystic Ovary Diagnosed by USG.
4.Clinical evidence of hyper androgens
 
 
ExclusionCriteria 
Details  1. Patient not willing for trial.
2.Patient below age of 18 Years above age of 40 years,
3.Patient of amenorrhea with congenital anomalies, chronic illness, chromosomal
abnormalities.
4.Cervical tumor, polyp, CA cervix
5.Uterine fibroids
6.Tubercular endometritis
7.Congenital adrenal hyperplasia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in the sign & symptoms from the treatment in the patients  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of tretment  3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   23/11/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is about comparing the efficacy of kaankayan vati and Erandmul Tailam Anuvasana Basti on Poly Cystic ovarian syndrome .there willbe 2 groups of 15-15 patients in which Group A patients will be treated with kaankayan vati orally 2 tab B.D. with lukewarm water. Group B patients will be treated with Erandmool anuvasan basti 25-40 ml per rectum 5 alternate days of menstrual cycles & kaankayan vati orally 2 tab B.D. with lukewarm water.  
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