| CTRI Number |
CTRI/2023/03/051015 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Yoga ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga in menstrual irregularities in female students |
|
Scientific Title of Study
|
Impact of Yoga Intervention in Menstrual Irregularities in Female Students of
Banaras Hindu University as per Prakriti. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Patel |
| Designation |
PHD Scholar |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Kriya Sharir, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9026819282 |
| Fax |
|
| Email |
garimadsvv97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sangeeta Gehlot |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Kriya Sharir, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453218571 |
| Fax |
|
| Email |
sangeetagehlot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sangeeta Gehlot |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Kriya Sharir, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453218571 |
| Fax |
|
| Email |
sangeetagehlot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Kriya Sharir, Faculty of Ayurveda, Institute of medical sciences, Banaras Hindu University, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Garima Patel |
Department of kriya sharir, faculty of Ayurveda, IMS, BHU |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Garima Patel |
Banaras Hindu University, Varanasi |
Banaras Hindu University, girls hostel (MMV girls hostel and Triveni complex girls hostel,)
Varanasi
UTTAR PRADESH |
9026819282
garimadsvv97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:A validated 60 minutes Yoga protocol for 5 days a week for 3 months will be given. Yoga protocol includes Asana, Pranayama, Meditation, Kriya, and Relaxation. As well as diet modification will also be advised, Pathya/Apathya:yes, Pathya:Diet modification includes 12 modules of group discussion/counseling/ Training/ awareness regarding healthy (Pathya) and Unhealthy (Apathy) diets., Apathya:Unhealthy diets (Apathy Ahara) such as refrigerated items, bakery items (cakes, biscuits, chocolate), fast food items (Pizza, Burger, pasta, Chowmin, Maggie), use of sweets, chips, aloo Bhujiya, samosa, curd, paneer, cheese, butter, white flour items, cold water/ carbonated drinks will be advised to avoid | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Diet modification includes 12 modules of group discussion/counseling/ Training/ awareness regarding healthy (Pathya) and Unhealthy (Apathy) diets., Apathya:Unhealthy diets (Apathy Ahara) such as refrigerated items, bakery items (cakes, biscuits, chocolate), fast food items (Pizza, Burger, pasta, Chowmin, Maggie), use of sweets, chips, aloo Bhujiya, samosa, curd, paneer, cheese, butter, white flour items, cold water/ carbonated drinks will be advised to avoid. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. The female subjects aged between 18-35 years.
2. Subjects willing to participate in the study for 3 months.
3. The subjects have symptoms of menstrual irregularities such as Oligomenorrhea,
Hypomenorrhea, Amenorrhea, Polymenorrhea, and Menorrhagia as per the criteria of the
Federation of International Gynecologists and Obstetricians.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are in use of oral contraceptives/hormone treatment/insulin-sensitizing agents within the previous six weeks.
2. Subjects who are addicted to alcohol, or smoking.
3. Subjects who have Hyperprolactinemia, thyroid abnormalities, and non-classic adrenal and
hyperplasia.
4. Patients who have Primary amenorrhea, premature ovarian failure, absence of ovary and uterus and other gynaecological disorders.
5. The Subjects suffer from diabetes mellitus, hypertension, congenital adrenal hyperplasia,
and renal failure.
6. Subjects with evidence of malignancy.
7. Subjects suffering from major systemic illness necessitating long-term drug treatment (Coronary Artery Disease, Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
8. Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc., or any other drugs that may influence the study’s outcome.
9. Subjects who have completed participation in any other clinical trial during the past six
months.
10. Subjects who are practicing Yoga or any other physical activity regularly. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of Yoga intervention on the pattern of menstruation in terms of LMP, duration, flow, cycle length and regularity at 4th, 8th and 12th week. |
Three months with 3 follow-ups of one month each. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the impact of Yoga intervention in Agni bala at 4th, 8th, 12th week.
2. To assess the impact of Yoga intervention on perceived Stress at 4th, 8th, and 12th week.
3. To assess the impact of Yoga intervention on BMI at 4th, 8th and 12th week.
4. To assess the impact of Yoga intervention in FSH, LH, TSH, and PRL at the day 1 and at 12th week. |
1. Agni, Stress, and BMI will be checked for three months with 3 follow-ups of one month each.
2. FSH, LH, TSH, and PRL will be assessed before and after the trial of three months. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menstrual irregularity is a major gynecological problem among women of reproductive age. It is very common among university students. It affects the daily activities, quality of life, and academic performance of female students. Moreover, studies revealed that menstrual irregularity has also a longer impact on later life, such as osteoporosis, infertility, future diabetes mellitus (DM), and cardiovascular disease. So, this research work has been planned to study the impact of Yoga intervention on menstrual irregularity on subjective and objective parameters in female students of BHU. The participants will be in the age group of 18-35 years of female students of BHU. The participants will be evaluated by detailed history taking, physical examination, different Prakriti (constitution), Agni (Digestive power), and stress levels. Blood samples will be taken for hormonal parameters. |