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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N812||Incomplete uterovaginal prolapse. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (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))
| 2 | Intervention Arm | Procedure | - | 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 |
|
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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. |