| CTRI Number |
CTRI/2024/09/073363 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Diagnostic Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda regimen and yoga therapy in pelvic floor muscle weakness |
|
Scientific Title of Study
|
Efficacy of Palashadi taila Yoni pichu with Moolabandha yoga therapy in women with Pelvic floor muscle weakness†– An open label clinical trial |
| 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 Janhavi Vishwas Jadhav |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka India |
| Address |
Department of Prasooti Tantra Evum STreeroga
KAHER Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9561307490 |
| Fax |
|
| Email |
janhavi.jadhav6429@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Girija Sanikop |
| Designation |
Professor and HOD Department of Streeroga and Prasooti Tantra |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka India |
| Address |
Department of Prasooti Tantra Evum STreeroga
KAHER Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9844362838 |
| Fax |
|
| Email |
gram.belgaum@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Girija Sanikop |
| Designation |
Professor and HOD Department of Streeroga and Prasooti Tantra |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka India |
| Address |
Department of Prasooti Tantra Evum STreeroga
KAHER Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9844362838 |
| Fax |
|
| Email |
gram.belgaum@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India Pin code 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Janhavi Jadhav |
| Address |
Department of Prasooti Tantra Evum Streeroga KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India Pin code 590003 |
| 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 Janhavi Jadhav |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India |
OPD Number 23 Prasooti Tantra Evum Streeroga Belgaum KARNATAKA |
9561307490
janhavi.jadhav6429@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O758||Other specified complications of labor and delivery. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: yogaratnakar 71/107, Procedure details: Palashadi taila yoni pichu from 6th day of menstrual cycle till 12 th day per vaginal for two cycles with the retention time of 3 to 4 hours after insertion
It should be followed with moolabandha yoga therapy for 2 consecutive months except 4 to 5 days of menstrual cycle for 8 to 10 times twice a day)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Primi para and multi para
2 Delivered by C-section or vaginal delivery or forceps or vacuum delivery or any traumatic labor
3 1st degree or 2nd degree uterine prolapse
4 Women accomplishing the diagnostic criteria
5 Willing to participate
|
|
| ExclusionCriteria |
| Details |
1 Women who have undergone surgery for the pelvis and have sling or surgery for prolapse or have malignancy of pelvic organs
2 Stress urinary incontinence with a history of UTI
3 Systemically confirmed clinical diseases such as neurological conditions cardiac insufficiency and other major systemic diseases
4 Women with faecal incontinence
5 Women with a history of cystocele enterocele rectocele urethrocele omentocele
6 If the patient conceives during treatment it will be considered as dropout
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Perineometer for assessing vaginal wall pressure
2 Modified Oxford Scale by vaginal digital palpation
3 PERFECT Score for evaluation of contractility of PFM
|
Baseline
61th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 The pelvic floor distress Inventory Questionnaires 20 which is designed to evaluate what extent the lower urinary tract gastrointestinal tract and pelvic organ prolapse symptoms affect the quality of life
2 The Female sexual dysfunction Index FSFI 6 is a questionnaire validated for clinical evaluation of female sexual dysfunction in six terms
3 Cough stress test for stress urinary incontinence done in the supine position
4 Quality of life scale questionnaire
|
Baseline
61st day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="2" Months="0" 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
|
Pelvic floor muscle weakness is a common condition that results in pelvic floor dysfunction having a serious negative impact on women’s lives presenting with a series of symptoms covering different degrees of pelvic organ prolapse, urinary incontinence, sexual dysfunction, fecal incontinence, chronic pelvic pain, etc which can present separately or co-exist. Reduced pelvic floor strength is seen in women who experienced vaginal delivery and had episiotomy or instrument or traumatic delivery. Vaginal deliveries can cause morphological alterations along with levator ani muscle injuries in 13-36% of women increasing the risk of urinary incontinence and uterine prolapse. 57.7% of women were identified to have the risk of pelvic floor dysfunction. Studies have shown 93.2% of women reported pelvic pain followed by 82.4% having urinary incontinence and 1.4% had reported pelvic organ prolapse. According to a study done in Karnataka state, the prevalence was reported to be 21%, with 19.02% of women experiencing urinary incontinence and 1.99% having pelvic organ prolapse. Studies have shown an increasing prevalence rate of such conditions in developing countries like India. Women’s sexual health is affected by many factors which include pregnancy and childbirth along with biological, psychological, and social changes in women’s bodies which affect quality of life and sexual function. Severe perineal trauma has shown effects on sexual functions according to studies done. Urinary incontinence is defined as ‘’the complaint of any involuntary urine leakage’’ by the International Continence Society (ICS). The prevalence of urinary incontinence among women ranges from 25% to 45% according to previous studies. Pregnancy, labor, vaginal delivery, and other surgeries are predominant contributing factors. Compared to vaginal delivery, C- section is also not completely protective. Women after experiencing these symptoms are hesitant to seek medical care due to lack of awareness or embarrassment. Targeted educational interventions that empower women to prioritize their pelvic health are needed so that women feel more comfortable in discussing their symptoms and seeking appropriate care. Due to the reasons mentioned earlier, its implication in public health, and its far-reaching benefits for the overall well-being of women and to improve the quality of life of women this research work has been taken. |