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CTRI Number  CTRI/2023/12/060751 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 22/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Agnimukha Churna in patients with Udavartini Yoni Vyapad (Primary Dysmenorrhea) & compare the efficacy of this drug with Rajahpravartini Vati . 
Scientific Title of Study   A randomized controlled clinical study to evaluate the effect of Agnimukha Churna 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  Chinmayi M S 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Department of PG Studies Prasooti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9663510951  
Fax    
Email  drchinmayims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha BK 
Designation  Associate Professor 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Associate Professor Department of PG Studies Prasuti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9008979169  
Fax    
Email  drkavithapradeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chinmayi M S 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Department of PG Studies Prasooti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9663510951  
Fax    
Email  drchinmayims@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College And Hospital Moodbidri Dakshin Kannada Karnataka 574227 
 
Primary Sponsor  
Name  Chinmayi M S 
Address  PG Scholar Alvas Ayurveda Medical College Moodbidri , DK , Karnataka 
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 
Chinmayi M S  Alvas Ayurveda College And Hospital , Moodbidri  Department of PG Studies Prasooti Tantra And Stree Roga Alvas Ayurveda Medical College and Hospital Moodbidri , Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA 		 9663510951

drchinmayims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL , MOODBIDRI   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
1Comparator ArmDrugClassical(1) Medicine Name: Rajahpravartini vati, Reference: Bhaishajya Ratnavali– Streeroga Adhikakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -Sukoshana jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Agnimukha churna, Reference: Yogaratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -Sukoshana jala), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patient fulfilling any of the following diagnostic criteria will be selected for the study.
1. Pain in the lower abdomen which begins one or two days before menstruation or with the onset of menstruation and lasting for few hours or one to two days.
2. Pain in the lower abdomen and suprapubic region, radiating to medial aspect of the thighs and lower back.
3 .Painful menstruation also associated with symptoms like headache, fatigue, nausea, vomiting and constipation.
4 .Age between 16 to 30 years
5. Married or unmarried females
6.History of painful menstruation for at least 3 consecutive cycles
7.Patients with regular menstrual cycles (21 to 35 days)



 
 
ExclusionCriteria 
Details  1.Cases of secondary dysmenorrhea with pelvic pathology – Fibroid uterus, endometriosis, Adenomyosis, AUB, PID, Ovarian cyst, cervicitis.
2. Patients with Congenital anomalies of Reproductive tract
3.Patients with systemic diseases like Diabetes Mellitus, Hypertension, Anaemia
4.Patients on Hormonal therapy, contraception and Intra uterine contraceptive device.
5.Endocrinal disorders like thyroid abnormalities and PCOS
6.Surgical and Malignant conditions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain criteria will be assessed using VAS grading.
a) Intensity of pain
b) Site of pain
c) Pain associated with symptoms such as nausea, vomiting, headache, constipation & fatigue.
d) Duration of pain
e) Nature of pain
 		 4th day of each menstrual cycle for 3 consecutive cycles.
 
 
Secondary Outcome  
Outcome  TimePoints 

a) Intensity of pain: VAS Scale: Mild / Moderate / Severe

b) Site of pain: Lower abdomen & suprapubic region
Lower back

c) Associated symptoms: Headache, fatigue, nausea, vomiting and constipation.

d) Duration of pain: Upto 24 hours/ 24 to 48 hours/ 48 to 72 hours.

e) Nature of pain: Dull / Colicky / Spasmodic

 		 For 1 cycle on the 4th day of menstrual cycle after treatment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/01/2024 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 12-09-2024 and end date provided 12-09-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Many drugs are used for internal administration, external application and preventive measures have been described in Ayurveda Samhitas and modern science to overcome UDAVARTINI YONIVYAPAD/ Primary Dysmenorrhea. So a remedy which would be economical ,efficacious and benefits the larger scale of community. Therefore an attempt was made to study the clinical evaluation of Agnimukha Churna in the management of Udavartini yonivyapad and compare its efficacy with the Rajahpravartini vati. 
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