| CTRI Number |
CTRI/2025/08/093370 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand the effect of erandmool arka in udavartini yonivyapad |
|
Scientific Title of Study
|
Randomised controlled clinical control study to evaluate the efficacy of erandmool arka in udavarta yonivyapad with special refference to primary dysmenorrhoea |
| 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 Dhanashri Devendra Shrikhande |
| Designation |
PG Scholar |
| Affiliation |
Shree Sapatashrhungi Ayurved Mahavidyalay |
| Address |
Department of Streerog and Prasutitantra OPD no 4 Ground Floor Shree Sapatashrhungi Ayurved Mahavidyalay and Hospital Nashik Kamal Nagar Panachavati Nashik 422003 Nashik Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
7709719742 |
| Fax |
|
| Email |
beingdhanashri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Sadashiv More |
| Designation |
HOD and Proffesor Prasutitantra and Strirog department |
| Affiliation |
Shree Sapatashrhungi Ayurved Mahavidyalay |
| Address |
Department of Streerog and Prasutitantra OPD no 4 Ground Floor Shree Sapatashrhungi Ayurved Mahavidyalay and Hospital Nashik Kamal Nagar Panachavati Nashik 422003 Nashik Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423934505 |
| Fax |
|
| Email |
moresunil263@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Sadashiv More |
| Designation |
HOD and Proffesor Prasutitantra and Strirog department |
| Affiliation |
Shree Sapatashrhungi Ayurved Mahavidyalay |
| Address |
Department of Streerog and Prasutitantra OPD no 4 Ground Floor Shree Sapatashrhungi Ayurved Mahavidyalay and Hospital Nashik Kamal Nagar Panachavati Nashik 422003 Nashik Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423934505 |
| Fax |
|
| Email |
moresunil263@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptashrungi ayurved mahavidyalaya and hospital nashik |
|
|
Primary Sponsor
|
| Name |
Dr. Dhanashri Devendra Shrikhande |
| Address |
House No 36 Vaibhav Nagar Near Rajani Managalam Revasa Road Amaravati 444602 |
| 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 Dhanashri Devendra Shrikhande |
Shree saptashrungi ayurved mahavidyalaya and hospital kamal nagar hiravadi nashik |
Department of prasutitantra and strirog opd no 4 ground floor shree saptashrungi ayurved mahavidyalaya and hospital kamal nagar panchavati nshik
Nashik
MAHARASHTRA |
7709719742
beingdhanashri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik |
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: erandmoolark, Reference: arkaprakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | mefinemic acid | Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain. It may also be used to treat menstrual cramps. it is a antispasmodic. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
clinically diagnosed cases of udavarta yonivyapad will be taken for study
patient coming with chief complaints of painful menses suffering for at least 3 consecutive menstrual cycles
patients with regular menstrual cycles and adequate menstrual flow
not associated with any organic reproductive system abnormalities
patients ready to participate in study with proper consent |
|
| ExclusionCriteria |
| Details |
patient having secondary dysmenorrhea
patient age below 15 year and above 30 year
anc and pnc patient
patient on harmonal therapy or using an IUCD
patient having any uterine or pelvic pathology
patient with history of hypo/hyperthyroidism DM cardiovascular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce pain before menses and during menses |
reduce pain before menses and reduce symptoms of udavartini yonivyapd |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no recurrence of symptoms of udavartini yonivyapad |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2025 |
| 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="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
|
Topic Randomised control clinical trial to study the efficacy of erandmool arka in udavarta yonivyapad with special reference to primary dysmenorrhoea
Materials and methods There will be two groups as control group A and trial group B group A will be given mefenamic acid 250mg bd for 3 days and group B will be given erandmool arka 10 bd with koshna jal for 7 days before menses and follow up will be taken on fifth day of three consecutive menstrual cycle
Assessment criteria Assessment will be done on what percentage of pain level will be reduced result and inference will be drawn on data collected by above methods |