| CTRI Number |
CTRI/2024/07/071561 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| 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 Study to Evaluate the Effect of Misreya Arka in painful Menstrual cycle
|
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Misreya Arka In The Management Of Udavartini Yoni Vyapad With Special Reference To 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 Uthiraleka G |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9786175553 |
| Fax |
|
| Email |
uthiralekag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Kagga |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uthiraleka G |
| Designation |
PG Scholar |
| Affiliation |
ri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9786175553 |
| Fax |
|
| Email |
uthiralekag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science and Research Hospital Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Uthiraleka G |
| Address |
Sri Sri College Of Ayurvedic Science and Research, Kanakapura Road, Udayapura P.O,560082 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College Of Ayurvedic Science and Research |
Kanakapura Road,Udayapura PO 560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uthiraleka G |
Sri Sri College Of Ayurvedic Science and Research Hospital |
Department Of Prasuti Tantra and Stree Roga, Room no.10,Sri Sri College Of Ayurvedic Scinece and Research Hospital, Kanakapura Road, Udayapura PO,Bangalore-560082
Bangalore
KARNATAKA |
9786175553
uthiralekag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Misreya Arka , Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: water), Additional Information: duration:7 days before Menstruation till 3rd day of cycle | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeeja Arka, Reference: Arka Prakasha , Route: Oral, Dosage Form: Arka, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: water), Additional Information: duration: 7 days before Menstruation till 3rd day of cycle |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects between the age group of 18-35 years irrespective of Marital Status.
2.Subjects with classical symptoms of Udavartini Yoni Vyapad.
3.Subjects with clinical signs and symptoms of Primary Dysmenorrhea.
4.Painful Menstruation for atleast 2 consecutive cycles.
5.Subjects with regular Menstrual cycle.
6.Subjects willing to sign the consent form.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant decrease in the symptoms of Udavartini Yoni Vyapad w.s.r to Primary Dysmenorrhea assessed based on WaLIDD score, Wong baker pain Scale and Numerical rating scale .
|
1st Assessment- after 1st cycle
2nd Assessment- after 2nd cycle
follow up-after 3rd cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in- depth analysed data on the different aspect of the disease.
Generation of data on possible unexpected drug reaction.
|
1st Assessment- after 1st cycle
2nd Assessment- after 2nd cycle
follow up-after 3rd cycle
|
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="6"
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
|
Dysmenorrhea
is a Greek term for “Painful Monthly Bleedingâ€. In Ayurveda
it can be seen as a cardinal feature in Udavartini Yoni Vyapad.
In Udavartini Yoni Vyapad vitiated Apana
Vayu cause Rajaso Gamanadurdhwam which leads to Krcharthava,
Badha Raja, Samanthath Varthanam Vayo are some of the Lakshana told
by various authors.
Symptoms
of Udavartini Yoni Vyapad can be compared to Primary Dysmenorrhea. Primary
Dysmenorrhea refers to presence of painful menses where there is no underlying pathology
that can account for pain
In
India the prevalence of Dysmenorrhea is 70.2%, one of the studies
shows that prevalence varies from 54% to 70.3% conducted in different states of
India.
Vata
Vigunya is the
main pathology in Udavartini Yoni Vyapad, the drug which can correct Vata
Vigunya, Shoolahara is beneficial in managing pain during
menstruation. The drug Misreya has the special property of Yonishoolahara,
when given in the form of Arka may have more potent in reducing pain
during menstruation.
According
to Arka Prakasha, Arka is one among of the Panchavidha Kashaya
Kalpana. Misreya Arka is having Yoni Shoolahara, Agnimandhyahara property,
hence it might be beneficial in managing the symptoms of Udavartini Yoni Vyapad,
hence this is taken for the study.
|