| CTRI Number |
CTRI/2022/11/047041 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Arogya rakshak panchatantra for dysmenorrhoea |
|
Scientific Title of Study
|
"Effect of Arogya Raksha Panchatantra (five lifestyle principles) on Heart rate variability, Health related quality of life, performance and self-efficacy in Young female adults with primary dysmenorrhea. A Randomized
control trial, Version 1.0" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karishma silwal |
| Designation |
MD Scholar |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8319691986 |
| Fax |
|
| Email |
silwalkarishma2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep MK Nair |
| Designation |
Research head |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9823262179 |
| Fax |
|
| Email |
drpradeep18bnys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karishma silwal |
| Designation |
MD Scholar |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal |
| Address |
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Sant hirdaram medical college of naturopathy and yogic science, Bairagarh, Bhopal, Pincode - 462030
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
8319691986 |
| Fax |
|
| Email |
silwalkarishma2018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Medical College of Natupropathy and Yogic SciencesLake road, Bairagarh, Bhopal, Pincode 462030 |
|
|
Primary Sponsor
|
| Name |
Sant Hirdaram Medical College of Natupropathy and Yogic Sciences |
| Address |
Lake road, Bairagarh, Bhopal, Pincode 462030 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karishma Silwal |
Sant hirdaram medical college of naturopathy and yogic science |
Room no9. Acupuncture department,Sant hirdaram medical college One tree Hill, Bairagarh, Bhopal, Pincode 462030
Bhopal
MADHYA PRADESH |
8319691986
silwalkarishma2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and yogic Sciences Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arogya rakshak panchatantra point 1 -Eat twice in a day |
2 heaalthy meals in an day that includs fruits , vegrtables, whole grains |
| Intervention |
Arogya rakahak panchatantra point 3-Fasting once in a week |
vegetable juices and water fasting once in a week |
| Intervention |
Arogya rakshak panchantantra
point 2-Drink 2 seers (8-10) liters of water in a day |
2 seers of water to flush toxins and promote health |
| Intervention |
Arogya rakshak panchatantra point -05- prayer twice a day |
Any form of prayer for 10 mins twice in a day |
| Intervention |
Arogya rakshak panchatantra point 4-exercise 1 hour daily |
Any form of exercise like yoga , walking , running , skipping |
| Comparator Agent |
Waitlisted control |
No intervention |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Regular menstrual cycle with cycle duration between 25-40 days
Vas score for pain >3 (at the time of screening)
No medical history of any gynecological diseases
Not taking any hormonal treatments
Nullipara
• Normal BMI (18-25)
• Those willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Participants with any known history of any systemic pathology
Menorrhagia
Habitual smoking, addiction
Those taking OCPs or any hormonal medications
BMI >25 and < 18
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effects of Arogya Raksha
Panchatantra (basic five lifestyle principles)
on autonomic flexibility using Heart rate
variability (HRV). |
Heart rate variability will be taken at baseline( 0 weeks ) , then 4 weeks, 8 weeks , 12 weeks and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the long-term association between dysmenorrhea and HRV
To study the impact of Arogya Raksha Panchatantra on primary dysmenorrhoea symptoms using a retrospective symptom scale (RSS).
To study the effects of the basic five lifestyle principles on quality of life using the SF-12 health questionnaire.
To study the effects of the basic five lifestyle principles on self-efficacy using a Generalized self-efficacy questionnaire.
To study the effects of the basic five lifestyle principles on sleep quality and daytime performance using the Epworth daytime sleepiness scale.
To document enduring health benefits of the basic five lifestyle principles in absenteeism, frequency of illness, academic performance among the study participants.
To understand the adherence of the study participants to arogya raksha panchatantras.
|
SF12, RSS, sleep scale, Efficacy questionnaire will be measured at baseline , after 3 months of intervention and at 6 months follow up
Self-reported VAS, sleep, and food diary will be measured daily till 6 months |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [silwalkarishma2018@gmail.com].
- For how long will this data be available start date provided 01-11-2022 and end date provided 01-11-2058?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - silwalkarishma2018@gmail.com
|
|
Brief Summary
|
Primary dysmenorrhea (PD) is one of the most prevalent gynecologic conditions, affecting approximately70% of adolescent and adult females.It is associated with various physical and psychological symptoms such as headache, lethargy, sleep disturbances, tender breasts, various body pains, disturbed appetite, nausea, vomiting, constipation, anxiety, depression, and irritability. Unlike secondary dysmenorrhea which is characterized by having some distinct pelvic pathology leading to pain, primary dysmenorrhea is associated with intrauterine secretion of prostaglandins F2α and E2 leading to uterine contractions and pain.PD is associated with lower quality of life and is one of the most common causes of poor school and work attendance and performance accounting for the loss of approximately 600 million work hours and over $2 billion annually. Conventional management of PD comprises NSAIDS and hormonal treatments which may not be viable treatments for all females because of contraindications and potential side effects, such as nausea, vomiting, GI bleeding, acne, and asthma especially when used for long.This necessitates a long-term and effective intervention which helps in the improvement of Quality-of-Life for women suffering from PD. Arogya rakshak Panchatantrs also called swastha rakshak Panchatantra are the five basic lifestyle principles of health preservation advocated by an Indian Naturopath Dr. V. Venkat Rao which are as follows . · Eat twice a day · Drink at least 2 seers (8-10) glasses of water in a day · Exercise daily for 1 hour · Fasting once in a week · Prayers twice a day Heart rate variability (HRV) is the variation in the duration between two adjacent heartbeats. Our mental attitude, emotions, stress, relaxation, and sleep influence the autonomic nervous system which comprises the sympathetic and parasympathetic nervous systems thereby influencing variability in heartbeats. Higher HRV is associated with attenuated resilience, self-regulatory capacity, emotional processing, performance, wellbeing, and lesser inflammation. The Time-domain and frequency-domain analysis of HRV is used widely as a biological marker of homeostatic status. Inflammation in our body is controlled by the autonomic nervous system. Excessive as well as poor inflammation is associated with a wide range of diseases. HRV assessment is a non-invasive technique that may help in the prognosis of inflammation levels in the body. Literature suggests that dysmenorrhea is associated with low heart rate variability. In such cases therapeutic interventions that target autonomic balance or improving HRV may be beneficial to patients suffering from PD. Evidence also shows that dysmenorrhoea is highly associated with stress, sedentary and unhealthy lifestyles in medical students.Evidences also shows that lifestyle interventions like good nutrition, yoga, exercises, and heat therapies are effective in improving dysmenorrhea-related outcomes.12However sustainability and adherence to such interventions among young females are not well documented. Therefore, this study intends to understand the long-term effect of Arogya rakshak Panchatantra as a sustainable intervention in reducing inflammation, restoring homeostasis, and thereby enhancing the quality of life in dysmenorrheic college girls. |