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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-yoni picu, योनि पिचु (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

 
 
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.

 
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