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CTRI Number  CTRI/2022/11/047242 [Registered on: 14/11/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect Of Tila Shelu Karvi Kwath With Hingu triguna Taila Matra Basti On Scanty Menses  
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Tila Shelu Karvi Kwath With Hingu Triguna Taila Matra Basti On Artvakshaya w.s.r.To Oligomenorrhea And Hypomenorrhea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeeta  
Designation  P.G. Scholar  
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College,Radaji Circle Ambamata,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8619822573  
Fax    
Email  sangeetabishnoi0505@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narendra Kumar Meena  
Designation  Associate Professor and Guide  
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College,Radaji Circle Ambamata,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Narendra Kumar Meena  
Designation  Associate Professor and Guide  
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G. Dept. of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College,Radaji Circle Ambamata,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt. Ayurved College Udaipur  
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College Radaji Circle Ambamata, Udaipur 313001 
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 
Dr Narendra Kumar Meena  Madan Mohan Malviya Govt. Ayurved College, Udaipur  OPD Room no.5,P.G.Dept.of Prasuti tantra evam Stri Roga Madan Mohan Malviya Govt. Ayurved College,Radaji Circle Ambamata,Udaipur
Udaipur
RAJASTHAN 		 9950129673

narendermeena42@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Madan Mohan Malviya Govt. Ayurved College, Udaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Tila Shelu Karvi Kwath, Reference: Yogratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Gud), Additional Information: -
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Astanghridya, Procedure details: 30 ml of hingu triguna taila is given to the patient rectally for 5 alternate days after stoppage of menstrual bleeding )
(1) Medicine Name: Hingu Triguna Taila , Reference: Astanghridya, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.patient willing for the trial.
2.patient between the age group of 16-40 years.
3.oligomenorrhea(delayed menses).
4.hypomenorrhea(scanty menses).  
 
ExclusionCriteria 
Details  1.patient in before 16 years after 40 years of age.
2.pregant women
3.lactating women.
4. HB level less than 7 gm%.5. patient having sex chromosomal abnormalities, congenital abnormalities( Turner syndrome etc.), patient suffering from chronic systemic disease and malignancy.
 
 
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 
1)Improvement in signs and symptoms of arthavakshaya
2) Improvement in menstrual
pain, duration of menstrual bleeding , amount of menstrual flow and interval between two cycles. 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)Improvement in signs and symptoms of arthavakshaya
2) Improvement in menstrual
pain, duration of menstrual bleeding , amount of menstrual flow and interval between two cycles. 		 15 days,30 days,45 days,60 days and 75 days 
 
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)   15/11/2022 
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 Yet Recruiting 
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 to evaluate the efficacy of Tila Shelu Karvi Kwath with Hingu Triguna Taila Matra Basti on Artvakshaya W.S.R. to Oligomenorrhea and Hypomenorrhea. This is single arm study so all 30 patients will be treated with Tila Shelu Karvi Kwath orally 40ml twice a day with gud and Hingu Triguna Taila Matra Basti 30 ml for 5 alternate days after stoppage of bleeding of menstrual cycle, per rectum. Trial  will be carried for  3 consecutive menstrual cycles. 
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