| CTRI Number |
CTRI/2024/10/075041 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Rasanadarvyadi kashay and Lodhrabilwadi kashay in the management of Udavartini Yonivyapad (Primary Dysmenorrhea). |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to Evaluate the Efficacy Of Rasanadarvyadi kashay in the management of 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 |
Bhagyashri Shivcharan Madghe |
| Designation |
PG SCHOLAR |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalya, Kanchanwadi, Aurangabad |
| Address |
OPD NO.19,Prasuti Tantra and StreeRog Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road,Aurangabad, 431011,Maharashtra.
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7038701010 |
| Fax |
|
| Email |
bhagyashrimadghe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandhya Madhukar Yennawar |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road,Aurangabad, 431011,Maharashtra. |
| Address |
OPD NO.19, Prasuti Tantra and Stri Rog Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road,Aurangabad, 431011,Maharashtra.
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9850562526 |
| Fax |
|
| Email |
dryennawar11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhagyashri Shivcharan Madghe |
| Designation |
PG SCHOLAR |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Aurangabad431011,Maharashtra |
| Address |
OPD NO.19,Prasuti Tantra and Stri Roga department,CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road,Aurangabad, 431011,Maharashtra.
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7038701070 |
| Fax |
|
| Email |
bhagyashrimadghe@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO.19, Prasuti Tantra and Stri Roga department,C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chh.Sambhaji nagar Maharashtra 431011 India |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Shivcharan Madghe |
| Address |
OPD NO.19,CSMSS Ayurved Mahavidyalaya and Rugnalya, kanchanwadi, Paithan road, Aurangabad 431011,Maharashtra. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhagyashri Shivcharan Madghe |
CSMSS Ayurved Mahavidyalaya and Rugnalya, Kanchanwadi, Paithan road, Aurangabad,431011, Maharashtra |
OPD NO.19,Prasuti Tantra and Stri Roga department,CSMSS Ayurved Mahavidyalaya and Rugnalya, Kanchanwadi, Paithan road, Aurangabad,431011, Maharashtra
Aurangabad
MAHARASHTRA |
7038701070
bhagyashrimadghe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS AURANGABAD |
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: Rasanadarvyadi kashay, Reference: Sahastrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lodhrabilwadi kashay, Reference: Sahastrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patient age group from 12 years to 30 years unmarried patient.
2.Patient with lower abdominal pain, lumbar pain, nausea,vomiting during menstrual cycle. |
|
| ExclusionCriteria |
| Details |
1.Patients of pelvic pathology i.e PID,PCOD,Cervical stenosis,Fibroid, Endometriosis,DUB,Adenomyosis,Endometrial polyp.
2.Patient taking anyn hormonal therapy.
3.Patient with Congenital Anomalies of reproductive system. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Rasanadarvyadi kashay in the management of Udavartini yonivyapad |
Baseline- 30th,60th,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study Udavartini yonivyapad according to Ayurveda.
2.To study Primary Dysmenorrhea according to Modern.
3.To compare the effect of Rasanadarvyadi kashay and Lodhrabilvadi kashay in the management of Udavartini Yonivyapad. |
Baseline- 30th,60th,90th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/10/2024 |
| 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 Applicable |
| 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
|
Udarvartini yonivyapad is one among the 20 yonivyapadas and mainly Vata predominance .Vata gets aggravated due to Vegdharan and moves in reverse direction then it settles in Yoni and produces Pain. Initially aartava pushes in upward direction and then discharged with difficulty. This condition is known as Udavartini yonivyapad or Kashtartava. For Udavartini yonivyapad ,Vitiated Vata is the Primary cause so vaatshamak and vaatanulomak dravyas have main role in treatment. In modern science, Primary Dysmenorrhea is managed by medical management which are not good for health for longer duration. Prevalence of dysmenorrhea is 70.2%. Majority of subjects experienced pain for 1-2 days during menstruation.23.2% girls experienced pain for 2-3 days during menstruation . In today’s world Dysmenorrhea is emerging issue and is increasing day by day. There is a need to solve this emerging problem.. In this condition, rather than hormonal treatment, Ayurvedic Formulations are proved effective in Dysmenorrhea. Rasanadarvyadi kashay contains drug which regulates Vitiated vata and lowers the discomfort cause due to dysmenorrhea.The contents of this kashay mainly belongs to Vedanasthapak and anulomak gana.Thus Udavartini yonivyapada occurs due to reverse movement of Apana Vaayu will be relieved by Rasanadarvyadi kashay by its vaatanulomak and vaatshamak properties . So,keeping all above things in mind Rasanadarvyadi kashay is selected to evaluate and establish safe, cost effective Ayurvedic remedy on Primary Dysmenorrhea. Study will be conducted on 100 diagnosed patients of Udavartini Yonivyapad.Written consent will be taken. Initial assesment will be done. Patient treated with interventional group Rasanadarvyadi kashay and Control group Lodhrabilwadi kashay. Patients will be assessed at follow ups. Observation and Results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn. |