CTRI

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CTRI Number

CTRI/2022/01/039573 [Registered on: 19/01/2022] Trial Registered Prospectively

Last Modified On:

29/09/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Other

Public Title of Study

Evaluation of the effect of Mutramargata Uttararabasti(Intravesical Drug Administration) with Shudhha Bala Taila on the Quality of Life of Cystocele patients

Scientific Title of Study

Evaluation of the change in Quality of Life of Cystocele Patients through Mutramarga Gata Uttarabasti with Shuddha Bala Taila- An Exploratory Study

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Karishma sharma
Designation	Post Graduate Scholar
Affiliation	All India Institute of Ayurveda
Address	Room no. 725,Department of Panchakarma,Academic Block,All India Institute of Ayurveda,Mathura Road,Gautampuri, Sarita Vihar, Delhi-110076 South West DELHI 110076 India
Phone	9871860583
Fax
Email	karishmasharma1412@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Anandaraman PV
Designation	Professor and Head of the Department
Affiliation	All India Institute of Ayurveda
Address	Room no. 725,Department of Panchakarma,Academic Block,All India Institute of Ayurveda,Mathura Road,Gautampuri, Sarita Vihar, Delhi-110076 South West DELHI 110076 India
Phone	9495130595
Fax
Email	dr.ananthramsharma@gmail.com

Details of Contact Person
Public Query

Name	Dr Prasanth Dharmarajan
Designation	Assistant Professor
Affiliation	All India Institute of Ayurveda
Address	Room no. 725,Department of Panchakarma,Academic Block,All India Institute of Ayurveda,Mathura Road,Gautampuri, Sarita Vihar, Delhi-110076 South West DELHI 110076 India
Phone	9895174060
Fax
Email	drprasanthd@gmail.com

Source of Monetary or Material Support

All India Institute of Ayurveda, Gautampuri , Sarita Vihar,Delhi-110076

Primary Sponsor

Name	All India Institute of Ayurveda
Address	All India Institute of Ayurveda, Mathura Road, Gautampuri, Sarita Vihar, Delhi-110076
Type of Sponsor	Research institution and hospital

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 Karishma Sharma	All India Institute of Ayurveda	OPD No.6, Hospital Block,All India Institute of Ayurveda,Mathura Road, Gautampuri, Sarita Vihar, New Delhi-110076 South West DELHI	9871860583 karishmasharma1412@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N811\|\|Cystocele. Ayurveda Condition: Cystocele with lower urinary tract Symptoms,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	uttarabastikarma	(Procedure Reference: Sushruta Samhita, Procedure details: There will be a single group in which Uttara basti will be given through urethral route with Shuddha Bala taila in a dose of 96 ml (1 Prasruta) consecutively for 7 days and the effects would be assessed.) (1) Medicine Name: Shuddha Bala Taila, Reference: Sahasrayogam, Route: Urethral, Dosage Form: Taila, Dose: 96(ml), Frequency: od, Duration: 7 Days

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Female
Details	1.Patients having clinical symptoms of cystocele 2.Patients diagnosed with grade I and grade II cystocele with or without urethrocele 3.Patients willing to participate in the study and willing to give written consent.

ExclusionCriteria

Details

1.Patients with severe systemic disorders
2.Pregnant females
3.Patients having malignancy
4.Patients having third degree uterine prolapse
(Procidentia)
5.Known cases of sexually transmitted diseases and
acute UTI
6.Uttarabasti Anarha
7.Patients with urethral stricture

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Improvement in the Quality of Life of Cystocele patients through P-QOL Status. 2.Improvement in the clinical Symptoms of Cystocele.	0th Day, 7th Day, 22nd Day

Secondary Outcome

Outcome	TimePoints
1.Reduction in the scores of UDI- 6, IIQ-7, POPDI-6 scales. 2.Improvement in Pelvic Organ Prolapse Quantification grading scale. 3.Finding a possible correlation of Cystocele in Ayurveda.	0th Day, 7th Day, 22nd Day

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

01/02/2022

Date of Study Completion (India)

26/08/2023

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="2"
Days="5"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

The results will be published in a peer-reviewed journal.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

BACKGROUND:Cystocele or prolapsed bladder is a common medical condition in which the urinary bladder herniates through the anterior vaginal wall and bulges in the vagina.It has a high impact on Quality of Life . It adversely affectsthe physiological as well as psychological health of the female and even interferes with their professional life.There are multiple underlying causes for the development of cystocele resulting in weakness of the muscles and the connective tissue surrounding the bladder and vagina or the pelvic floor support system. The main associated risk factors are obesity , increasing age, multiparity , heavylifting, pelvic muscle strain, chronically increased intra-abdominal pressure, collagen abnormality, family history of cystocele, and a history of pelvic surgery. The symptoms of cystocele include feeling of pelvic heaviness , a bulge in the vagina, 6 involuntary escape of urine in moments of stress on the pelvic floor such as hearty laughter, sneezing or coughing, frequency of urination, incomplete emptying of bladder, nocturnal awakening for the purpose of urination more than once or twice a night, urge incontinence and other symptoms of pelvic organ prolapse.

Conservative and surgical measures are available for its management in the contemporary science but they have their own drawbacks. The most commoncomplication of surgery is the recurrence of the prolapse and a need for further repair.Other complications include postoperative bleeding, hematoma, damage to the surrounding pelvic organs, infection of the operative site and dehiscence of the wound, infection of the urinary tract, pain during intercourse, urinary retention, and the formation of a vesicovaginal fistula.Conservative management has its own pitfalls. For example- vaginal pessaries can cause pain, erosion of the vagina, bleeding or infection. And, Kegels exercises have to be performed life-long and it is difficult to do these consistently due to busy schedule.

Due to the above-mentioned drawbacks, there is a clear need to explore and use Ayurvedic treatments given in Samhitas in order to minimize the complications and to provide a permanent cure. Ayurvedic classics have description of Mutramargagata Uttarbasti in Sushruta Samhita with Mutra dosha as well as Bastigata Roga as its indicationMutramargagata Uttarabasti is non-invasive, cost-effective, easily performed and can be done in OPD basis and is expected to give good results in a short time. Moreover, it has no complications or side effects. And Sneha is best for conditions in which Vata is deranged among which also, taila is best Vata shamaka. Moreover, in Shudhh Bala taila , taila is infused with Bala and ksheera and is therefore balya, brimhana and will work best for Apana Vayu Vaigunya.

OBJECTIVES OF THE RESEARCH PROJECT:

PRIMARY:

1. To assess the effect of Mutramarga gata Uttara Basti with Shudhha Bala taila on the quality of life of Cystocele patients through P-QOL status

2. To study the effect of Mutramarga gata Uttara Basti with Shudhha Bala taila on the signs and symptoms of Cystocele.

SECONDARY:

1. To study the changes in the symptoms of cystocele through P-QOL, UDI form-6, IIQ-7, and POPDI-6 scales.

2. Assessment of the effect on pelvic organ prolapse degree through Pelvic organ prolapse quantification system (POP-Q).

3. To understand Cystocele and its possible correlation in Ayurveda

METHODOLOGY

TYPE OF STUDY DESIGN Single arm open label exploratory study

STUDY TYPE- Interventional

INTERVENTION: There will be a single group in which Uttara basti will be given through urethral route with Shuddha Bala taila(14) in a dose of 96 ml (1 Prasruta) (15) consecutively for 7 days and the effects would be assessed

FOLLOW-UP:

At Baseline on 0th Day before coming for the Panchakarma Procedure, After Uttara basti on 7th day , After 14 days follow up (rest) period on 22nd day