| CTRI Number |
CTRI/2023/08/057139 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Shodhitha Hingu and Shodhitha Hingu with selected Yogasanas for the management of Primary Dysmenorrhea. |
|
Scientific Title of Study
|
A clinical study to assess the effect of selected yogasanas and shodhita hingu in the prevention of dysmenorrheic episodes- an open label double arm comparative clinical study.
|
| 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 Pallavi S L |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital,Mysuru |
| Address |
Room no 8,Department of swasthavritta,JSS Ayurveda Medical college and hospital, #41/E, Lalitadripura road,Mysuru-570028, Karnataka.
Mysore
KARNATAKA
570028
India |
| Phone |
9620232398 |
| Fax |
08212548360 |
| Email |
pallavishivu3638@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sudhakar Reddy |
| Designation |
Professor and Head |
| Affiliation |
JSS Ayurveda Medical College and Hospital,Mysuru |
| Address |
Room no 8,Department of swasthavritta, JSS Ayurveda Medical college and hospital,#41/E, Lalitadripura road, Mysuru-570028, Karnataka.
Mysore
KARNATAKA
570028
India |
| Phone |
9961483919 |
| Fax |
08212548360 |
| Email |
drpsreddy05@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Sudhakar Reddy |
| Designation |
Professor and Head |
| Affiliation |
JSS Ayurveda Medical College and Hospital,Mysuru |
| Address |
Room no 8,Department of swasthavritta, JSS Ayurveda Medical college and hospital,#41/E, Lalitadripura road, Mysuru-570028, Karnataka.
Mysore
KARNATAKA
570028
India |
| Phone |
9961483919 |
| Fax |
08212548360 |
| Email |
drpsreddy05@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda medical college and Hospital,Mysore |
|
|
Primary Sponsor
|
| Name |
Dr Pallavi S L |
| Address |
Room no 8,Department of swasthavritta,JSS Ayurveda Medical college and hospital, #41/E, Lalitadripura road, Mysuru-570028, Karnataka. |
| 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 Pallavi S L |
JSS Ayurveda Medical College and Hospital,Mysore |
Room No. 8, Department of Swasthavritta OPD,41/E, Lalithadripura Road, Mysore,Karnataka,570028
Mysore
KARNATAKA |
9620232398
pallavishivu3638@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College and Hospital,Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: Kashtartava , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shodhitha Hingu, Reference: bhava prakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Yogasanas | Yogasanas like Pavanamuktasana, Bhujangasana and Bhadrasana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Subjects fulfilling the diagnostic criteria.
Age between 18-28 years.
Known case of Dysmenorrhea for 4 consecutive cycles.
Subjects with regular menstrual cycles.
|
|
| ExclusionCriteria |
| Details |
Known case of Secondary Dysmenorrhea.
Subjects on hormonal therapy.
Subjects who are not willing to do Yoga.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the intensity & duration of pain in Primary Dysmenorrhea |
on 0th day,60th day and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of pain for 2-3 cosecutive cycles |
3 months |
|
|
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)
|
15/09/2023 |
| 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="3"
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 refers to pain that is not associated with any identifiable pelvic pathology. It is characterized by pain in the lower abdomen that may radiate to the thighs and lower back. Associated problems include nausea, vomiting, mood swings, headache, fatigue, diarrhea, constipation etc. Dysmenorrhea can be co related with kashtartava in Ayurveda. Apana Vata Dushti is considered as main cause for kashtartava .So we are using Shodhita Hingu as it is having Vatashamaka, Shoola Prashamana, Agnivardaka and Vatanulomana properties and Yogasanas which are non- phamancological, cost-effective and safe intervention useful in treating Primary Dysmenorrhea. Even slight reduce in the intensity of pain makes a big difference for the patient and the routine life of that individual will greatly differ. Hence, the present study is taken which is aimed to find the effect of Selected Yoga Techniques and Shodhitha Hingu in Primary dysmenorrhea. In this study 60 female subjects diagnosed with Primary Dysmenorrhea will be randomly allocated into 2 groups, Group A-30 subjects and Group B- 30 subjects Intervention of the study:
GROUP A:-Yogasanas will be demonstrated and asked to perform by the subjects Asanas: Bhadrasana, Pavanamuktasana, Bhujangasama at morning Medication: Shodhita Hingu should be consumed along with first bolus of the food(breakfast) for 30days Dose:250mg GROUP B Medication: Shodhita Hingu should be consumed along with first bolus of the food Dose:250mg Duration-30 days. |