FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072983 [Registered on: 27/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Interventional study on the effect of Shatapushpa Arka for Managing Menstrual Cramps in Young Women Participants. 
Scientific Title of Study   Clinical study to evaluate the effect of Shatapushpa Arka in the management of Primary Dysmenorrhea in young adult females. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharanya CB 
Designation  UG Scholar 
Affiliation  SDMIAH BANGALORE 
Address  SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Post Bengaluru-Mysore Highway Bengaluru- 560074

Bangalore
KARNATAKA
560074
India 
Phone  9741700359  
Fax    
Email  20a4406@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query  
Name  Sharanya CB 
Designation  UG Scholar 
Affiliation  SDMIAH BANGALORE 
Address  SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Post Bengaluru-Mysore Highway Bengaluru- 560074

Bangalore
KARNATAKA
560074
India 
Phone  9741700359  
Fax    
Email  20a4406@sdmayurbangalore.in  
 
Details of Contact Person
Public Query  
Name  Sharanya CB 
Designation  UG Scholar 
Affiliation  SDMIAH BANGALORE 
Address  SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Post Bengaluru-Mysore Highway Bengaluru- 560074

Bangalore
KARNATAKA
560074
India 
Phone  9741700359  
Fax    
Email  20a4406@sdmayurbangalore.in  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences. 2, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041. 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  12, 30th Cross Rd opposite to Sagar Hospital 4th T Block East Pattabhirama Nagar Jayanagar Bengaluru Karnataka 560041 
Type of Sponsor  Government funding agency 
 
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 Smitha Jain  SDM Institute of Ayurveda and Hospital Bangalore  Department of Rasashastra, Ground floor, OPD No.25. Anchepalya Kumbalagodu Post Bengaluru-Mysore Highway Bengaluru-560074
Bangalore
KARNATAKA 		 9480063676

sdmcabh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  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: Shatapushpa Arka/Mishreya Arka, Reference: Arka Prakasha Tritiya Shataka Shloka 11 , Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: 10 milliliters of Shatapushpa Arka will be administered orally twice a day after food with 20 milliliters of warm water for two menstrual cycles from 2 days prior to expected date of menstruation till the third day of menstruation.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  Single (unmarried), young adult females between 20 and 24 years of age.
Subjects having regular menstrual cycles in the interval of 21–35 days and bleeding duration of 3-7 days.
Subjects suffering from pain during menstruation for more than 2 consecutive menstrual cycles.
Lower abdominal and pelvic pain associated with onset of menses.
Onset of pain within 6–12 hours after onset of menses and pain lasting for 9–72 hours.
Subjects of Grade 1, 2 and 3 on the Verbal Multidimensional Scoring (VMS) System.

 
 
ExclusionCriteria 
Details  Female subjects with known history of Secondary Dysmenorrhea, Pelvic pathology, endometriosis, tubercular endometritis, polycystic ovarian syndrome.
Female subjects with known history of thyroid, pituitary and hypothalamic abnormalities, general diseases like tuberculosis, nephritis, diabetes and heart diseases.
History of any other surgical and neurological condition or surgery resulting in Dysmenorrhea.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in spasmodic lower abdominal pain as assessed in VMSS.
 		 Mentruation related spasmodic lower abdominal pain relief within 3 days of administration of trial drug.
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Associated Symptoms of Primary Dysmenorrhea as assessed in CMSS.  Relief within 3 days of administration of trial drug.
 
 
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 3 
Date of First Enrollment (India)   03/09/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Dysmenorrhea is a common gynecological complaint among adolescent and young adult females. Dysmenorrhea is usually primary and is associated with normal ovulatory cycles and with no pelvic pathology.  Primary Dysmenorrhea (ICD 10 diagnosis code- N94.4) refers to the presence of recurrent cramping pain in the lower abdomen during menstruation.  Primary Dysmenorrhea (PD) negatively impacts the Quality of Life by hampering the productivity and ability to perform their day to day activities. A cross-sectional study has shown 70.2% prevalence of dysmenorrhea in South Indian females aged 11-28 years. The goal of treatment is to provide adequate relief of pain. In contemporary science, NSAIDs, especially mefenamic acid, are the treatment of choice for Dysmenorrhoea. However they impart certain adverse effects, including indigestion, headaches and drowsiness etc. Due to the rising awareness about the substantial risk of adverse effects of these NSAIDs, considerable numbers of patients approach for Ayurvedic treatment.  Hence Dysmenorrhea is one of the common clinical entities encountered in regular Ayurvedic practice. 

In Ayurvedic classics, dysmenorrhea can be termed as Kashtartava. Kashtartava is a symptom in disease Udavartini Yonivyapat.

Ayurveda denotes the involvement of Vata in all different kinds of pain. The function of Apana Vayu is ensuring physiological downward expulsion of Artava. So any de-arrangement of Apana Vata causes painful menstruation. Therefore to reduce the symptoms of pain, Vata Anulomana (Normal course of movement of Vata) and Vatahara (Vata-pacifying), is the choice of treatment. Many Dravyas are mentioned in Ayurvedic Classics for Kashtartava, out of which Shatapushpa is one of them. Shatapushpa (Anethum graveolens Linn.) can be used in treatment of pain and other associated symptoms of dysmenorrhea as it is Vatahara, Yoni Shulaghna and  also Vata Anulomana.  Clinical trials on Shatapushpa in the form of Phala Churna and Shatapushpyadi Taila have proven significant effects in the management of Kashtartva. 

Phytochemical constituents of Anethum graveolens Linn. include volatile components, coumarins, terpenoids, flavonoids, phenolic acids and steroids. The terpenoid-carvone has antispasmodic effect. The flavonoid quercetin also has the ability to reduce PGF2α-elicited Ca2+ responses in human uterine smooth muscle cells and inhibit Ca2+-dependent uterine contractions. Other volatile compounds like α-phellandrene, limonene have analgesic effects too . 

Arka Kalpana is a unique pharmaceutical preparation in Ayurveda in which the volatile oil and active principles of a drug are collected by the process of distillation. Arka is the most efficacious and stable dosage form as explained in Arka Prakasha. So this study aims to administer Shatapushpa in the form of Arka (distillate). Hence this study is intended to evaluate the effect of Shatapushpa Arka in the management of PD in young adult females. 
Close