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CTRI Number  CTRI/2023/06/053711 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a comparative study of a locally placed drug and yoga with and without another oral drug in cases of yoni vyapad w.s.r to perineal laxity. 
Scientific Title of Study   a comparative clinical trial on udumbaradi pottali and yoga intervention with and without oral administration of phalaghrita in the management of yoni vyapad ( especially yoni bhransh ) w.s.r to perineal laxity.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vibha Parihar 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, LucknowState  
Address  department of prasuti tantra evam stree rog, state ayurvedic college and hospital, lucknow, uttar pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452196405  
Fax    
Email  vibha24parihar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashi Sharma 
Designation  Reader 
Affiliation  State Ayurvedic College and Hospital, LucknowState  
Address  department of prasuti tantra evam stree rog, state ayurvedic college & hospital, lucknow,uttar pradesh.
department of prasuti tantra evam stree rog, state ayurvedic college & hospital,lucknow,uttar pradesh.
Lucknow
UTTAR PRADESH
226003
India 
Phone  8795545443  
Fax    
Email  bedar.shashi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vibha Parihar 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, LucknowState  
Address  department of prasuti tantra evam stree rog, state ayurvedic college and hospital, lucknow, uttar pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452196405  
Fax    
Email  vibha24parihar@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital, Lucknow 
 
Primary Sponsor  
Name  STATE AYURVEDIC COLLEGE and HOSPITAL LUCKNOW 
Address  Post graduate department of Prasuti tantra evam Stree rog, department of prasuti tantra evam stree rog, state ayurvedic college and hospital, lucknow, uttar pradesh. 226003 
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 Vibha Parihar  state ayurvedic college and hospital  post graduate department of Prasuti tantra evam Stree Rog
Lucknow
UTTAR PRADESH 
9452196405

vibha24parihar@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:N812||Incomplete uterovaginal prolapse. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: sharangdhar samhita 11/110, Procedure details: pottali: a 15 gram udumbaradi pottali will be kept intravaginally for 10 consecutive days for 3 months in menopausal women. women of reproductive age group who have completed their families will be called for the same after clearance pf menses. yoga intervention : yoga session for 4 consecutive cycles. the duration of 30 minutes of yoga session will be as follows- 5 minute Asana ( muladhar bandh, baddha konasana, salabhasana, bhadrasana, bhujangasana, dhanurasana ) - 15 minutes pranayam - 5 m))
2Intervention ArmProcedure-yoni pichu (Procedure Reference: sharangdhar samhita 11/110, , Procedure details: pottali: a 15 gram udumbaradi pottali will be kept intravaginally for 10 consecutive days for 3 months in menopausal women. women of reproductive age group who have completed their families will be called for the same after clearance pf menses. yoga intervention : yoga session for 4 consecutive cycles. the duration of 30 minutes of yoga session will be as follows- 5 minute Asana ( muladhar bandh, baddha konasana, salabhasana, bhadrasana, bhujangasana, dhanurasana ) - 15 minutes pranayam - 5 m))
(1) Medicine Name: phalaghrita, Reference: ashtang sangrah uttar tantra 39/81, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Duration: 90 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.patient fulfilling cardinal symptoms of Yoni Bhransh;
2.patient having cystocele and rectocele; 3.multiparous women; 
 
ExclusionCriteria 
Details  1. Patient with vaginal infection;
2. Complete procidentia;
3. Patient who have completed their family;
4. Patient having systemic diseases like hypertension, diabetes mellitus, thyroid disorder with the present study;
5. Pregnant and lactating women;
6. Patients with OCPs and IUCDs;
7. Patient with any pelvic pathology or malignancy of genital organs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Relief in painful and burning micturition;
2. Relief in pain in back and lower abdomen and also pain during movement. 
90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Relief in feeling of heaviness in pelvic region;
2. Relief in vaginal discharge with heaviness in pelvic region. 
3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/06/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In Ayurveda, Aachryas’ have mentioned 20 types of yonivyapad which includes almost all types of gynaecological disorders due to vitiation of vata, pitta, kapha. Yoni bhransh is mentioned as a symptom of phalani, vatiki, prasramsini yoni vyapad. Yoni bhransh resembles with uterine prolapse and vaginal wall prolapse. It is a common condition which arises due to weakness of the supporting structures of female pelvis. It is characterized by descent of one or more of the pelvic organs through the potential space of vagina, heaviness in pelvic region, vaginal discharges, dyspareunia, painful, burning micturition. Purpose of this study is to evaluate role of udumbaradi pottali, phalaghrita nd yoga intervention for better therapeutic responses. All patients will be registered from OPD. Registered patients will be randomly divided into two groups. GROUP A patients will be given trial drug phalaghrita orally for 3 continuous months and udumbaradi pottali locally for 10 days for 3 months with yoga intervention for 30 minutes. GROUP B patients will be given the trial drug udumbaradi pottali for 10 days for 3 months along with yoga intervention. Followup will be done in every 15 days.  
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