| CTRI Number |
CTRI/2023/09/057578 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Oral Intake Of Eranda Taila In The Management Of Primary Dysmenorrhea. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial Of Oral Administration Of Eranda Taila In The Management Of Udarvartini Yonivyapada 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 Sneha Suresh Hake |
| Designation |
PG Scolar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Tal Walwa Dist Sangli
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
09167683706 |
| Fax |
|
| Email |
snehahake0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Vitthal Katare |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
3 rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra
3 rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Vitthal Katare |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
3 rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra
3 rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Sureshrao Hake |
| Address |
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor
Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli Tal
WalWa Dist Sangli MAHARASHTRA 416301 India
Sangli
Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 Sneha Suresh Hake |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta |
OPD no 6 Striroga And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
09167683706
snehahake0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethical Committee |
Not Applicable |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E308||Other disorders of puberty. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eranda Taila, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - Duration is 2 day before onset of menses for 3 consecutive cycle | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda taila, Reference: Sushrut samhita sutrasthana, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - 2 day in month for 3 month | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa churna, Reference: Sushrut samhita sutrasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - 2 days in a month for 3 month |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1 Painful Menstruation For Atleast 3 Consecutive Cycle
2 Patient With Regular Menstrual Cycle 21 to 35 days |
|
| ExclusionCriteria |
| Details |
1 Patient Having Secondary Dysmenorrhea Like Fibroid Adenomyosis Endometriosis
2 Severe Anemic Hb less than 7 gm percent
3 Abdominal Pain Associated With Excessive Bleeding Per Vagina
4 Irregular Menstrual Cycle
5 Any Other Abdominal Pain Like Gastritis Colitis
6 Polycystic Ovarian Disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of oral administration of eranda taila in the udavartini Yonivyapad With Special Reference Primary Dysmenorrhea |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare The Efficacy Of Oral Administration Of Eranda Taila And Shatpushpa Churna In The Udavartini Yonivyapad With Special Reference To Primary Dysmenorrhea |
Once in month for 3 months |
| To compare the efficacy of oral administration of eranda taila and shatpushpa churna in udavartini yonivyapad with special reference to primary dysmenorrhea |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/09/2023 |
| 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
|
Dysmenorrhea is cramping pain in lower abdomen occuring just before or during menstruation Dysmenorrhea effects 40 to 70% of women of reproductive age and effects daily activities in upto 10% of women Study is Randomized control clinical trial to check the effectiveness of Oral administration of Eranda Taila and Shatpushpa Churna in Udavartini Yonivyapad it’s having one trail group and one control group Eranda Taila 10ml OD on empty stomach for 2 days prior to onset of menstrual Cycle for 3 consective cycle Shatpushpa Churna 3gm BD for 2 days before onset of menstrual Cycle for 3 consective cycle Follow up on 5th day of every menstrual Cycle for 3 consective cycle 42 patients in each group will be studied Study will be conducted in India |