| CTRI Number |
CTRI/2024/03/064575 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Kuberakshayoga tablet in primary dysmenorrhea |
|
Scientific Title of Study
|
Randomised control trial on the efficacy of kuberakshayoga tablet in 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 NOBLETM |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GOVT.AYURVEDA COLLEGE,TRIPUNITHURA |
| Address |
DEPARTMENT OF RASASASTRA AND BHAISHJYAKALPANA,GOVT.AYURVEDA COLLEGE , TRIPUNITHURA -682301
ERNAKULAM,KERALA,INDIA
Ernakulam
KERALA
682301
India |
| Phone |
9400829878 |
| Fax |
|
| Email |
noble@ayurvedacollege.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANSARY P Y |
| Designation |
PROFESSOR |
| Affiliation |
GOVT.AYURVEDA COLLEGE,TRIPUNITHURA |
| Address |
DEPARTMENT OF DRAVYAGUNAVIJNANAM ,GOVT.AYURVEDA COLLEGE , TRIPUNITHURA -682301
ERNAKULAM,KERALA,INDIA
Ernakulam
KERALA
682301
India |
| Phone |
9447568388 |
| Fax |
|
| Email |
dransarypy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NOBLETM |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GOVT.AYURVEDA COLLEGE,TRIPUNITHURA |
| Address |
DEPARTMENT OF RASASASTRA AND BHAISHJYAKALPANA,GOVT.AYURVEDA COLLEGE , TRIPUNITHURA -682301
ERNAKULAM,KERALA,INDIA
Ernakulam
KERALA
682301
India |
| Phone |
9400829878 |
| Fax |
|
| Email |
noble@ayurvedacollege.ac.in |
|
|
Source of Monetary or Material Support
|
| Govt.Ayurveda college Hospital ,Thripunithura |
|
|
Primary Sponsor
|
| Name |
Kerala university of health sciences |
| Address |
Kerala university of health sciences, Medical college P.O, Thrissur, Kerala -680596 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrNobleTM |
Govt.Ayurveda college Tripunithura |
Rasa sastra Bhaishajya kalpana departmentment,OPNO-2,Room number-2
Ernakulam
KERALA |
9400829878
noble@ayurvedacollege.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT.AYURVEDA COLLEGE TRIPUNITHURA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kuberaksha yoga, Reference: Vaidyachintamani Shoola chapter, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -kuberakshayoga tablet will be given from 23rd of menstruation upto 3rd day of menstruation | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravarthini vati, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -Rajapravarthini tablet will be given from 23rd day of menstruation to 3rd day of menstruation |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
females with primary dysmenorrhea on basis of sign and symptoms with regular periods will be taken for study. |
|
| ExclusionCriteria |
| Details |
patients having any organic pathology of uterus and adnexae.
patients with intrauterine contraceptive devices.
patients with menorrhagia and metrorrhagia.
patient planning for pregnancy.
patients having menstrual period interval less than 21 days or more than 35 days |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in mean score value of pain in primary dysmenorrhea |
patient is advised to report in OP,during 4th day of menstruation, for 2 months and during follow up after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in associated symptoms of primary dysmenorrhea Nausea,Vomiting,fatigue,headache,fainting Sweat,Diarrohea,constipation,Vaginal discharges,Breast tenderness |
4th day day of menstruation for 2 months and during follow up after 1 month |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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
|
primary dysmenorrhea is painful menstruation affecting 70% of women with varying degrees of discomfort .kuberaksha yoga tablet and Rajapravarthinitablet is from classical text of Ayurveda like Vaidyachintamani and Bhaishjyaratnavali respectively which is having specific action on primary dysmenorrhea .Literary review of ingredients of both medicines shown action on pain.
patients who fulfill inclusion criteria will be randomly selected and medicine given from 23rd day of last period to 3rd of period for 2 months and patient will be advised to come on 4th day for assesment,and follow up will be for 1 month.
Relevent statistical test will be done to find the efficacy of kuberaksha tablet comapring to Rajapravarthini tablet. Kuberaksha tablet will be choice of treatment for primary dysmenorrhea if proven for efficacy and that to with very few ingredient.
it is a PhD study done under kerala university of health sciences.After study it will be under university for further evaluation.Data will be published on recognised peer revieved journal as per university instruction |