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CTRI Number  CTRI/2025/03/082870 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Erandamoola Distillate and Udavarta Roga Nashaka Distillate in Painful Menstruation. 
Scientific Title of Study   Comparative clinical study to evaluate the effectiveness of Erandamoola Arka and Udavarta Roga Nashaka Arka in Udavartini Yonivyapad (Primary Dysmenorrhea). 
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 Anuradha Subhas Shivanagudi 
Designation  Postgraduate Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  7090093411  
Fax    
Email  anuradhashivanagudi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhu M 
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  8970167939  
Fax    
Email  drmadhu.ayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhu M 
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  8970167939  
Fax    
Email  drmadhu.ayu@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, Pin-573201 India Phone No-08172256460 , Email- sdmcah@gmail.com 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, Pin-573201 India Phone No-08172256460 , Email- sdmcah@gmail.com 
Type of Sponsor  Private 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 Anuradha Subhas Shivanagudi  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA 		 7090093411

anuradhashivanagudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Erandamoola Arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Udavarthaka Roga Nashaka Arka , Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Subjects having spasmodic type of pain during menstruation which is confined to lower abdomen or radiates to back and medial aspects of thighs with or without associated symptoms like nausea, vomiting, fatigue, giddiness, constipation, headache and diarrhea.
2. Age between 18-40years.
3. Regular menstrual cycle.
4. Willing to sign the informed written consent form.
 
 
ExclusionCriteria 
Details  1. Known case of HIV, HBsAg, VDRL.
2. Subjects with IUCD.
3. Secondary dysmenorrhea.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of pain, site of pain, intensity of pain are to be assessed by WaLIDD Scores.  0th day, 5th day of 2 menstrual cycles during treatment and 5th day of 3rd cycle without treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the lifestyle.  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   Phase 2 
Date of First Enrollment (India)   18/04/2025 
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="2"
Months="0"
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  

Primary dysmenorrhea is prevalent gynecological condition that affects a large proportion of woman and have significant impact on their quality of life. It is characterized by severe lower abdominal pain and discomfort that can range from mild to debilitating. The pain is typically felt before or during menstruation and may be accompanied by other symptoms such as nausea, headache and fatigue. In India the prevalence rate varies between 50-87.8%.

Udavartini yonivyapad is one among 20 yonivyapad, can be corelated with primary dysmenorrhea. Nidana, samprapti and roopa of Udavartini yonivyapad can be well explained with etiopathogenesis and clinical features of primary dysmenorrhea. Arthave sa vimukthe tu tat kshanam labhate sukham substantiate the comparison of Udavartini with primary dysmenorrhea.Owing to svaprakopaka nidana such as vegavadharana and vata prakopaka ahara vihara, menstruation becomes painful in Udavartini  yonivpad due to pratiloma gati of apanavata. Previously numerous studies have been conducted for same condition on shodana karmas mainly basti and other oral medications. Arka kalpana which is very unique form of medicine by its palatability, high potency and minimum dose, and is less explored form of medicine. Erandamoola Arka attributes to vatahara and shoolahara property which is selected for the present study and will be compared to Udavarta Roga Nashaka Arka, which is already proven to have significant results in management of primary dysmenorrhea. 
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