| CTRI Number |
CTRI/2023/07/055030 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Mulbandha and Matra Basti along with Pichu Dharan in Uterine Prolapse |
|
Scientific Title of Study
|
An Anatomico clinical study on comparative effect of Mulbandha and Matra Basti along with Pichu Dharan in Yonibhransha with special reference to to 1st and 2nd Degree Utero-vaginal Prolapse |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Paijwar |
| Designation |
Ph.D Scholar |
| Affiliation |
Faculty of Ayurveda IMS BHU Varanasi |
| Address |
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813194 |
| Fax |
|
| Email |
pinkcity11011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof H H Awasthi |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda IMS BHU Varanasi |
| Address |
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813194 |
| Fax |
|
| Email |
hhawasthi10@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Paijwar |
| Designation |
Ph.D Scholar |
| Affiliation |
Faculty of Ayurveda IMS BHU Varanasi |
| Address |
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9926952316 |
| Fax |
|
| Email |
pinkcity11011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi |
| Address |
Dept of Rachana Sharir Faculty of Ayurveda IMS BHU Varanasi |
| 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 Deepa Mishra |
Sir Sundarlal Hospital |
OPD 24 Department of Prasuti Tantra Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH |
9650453095
deepa1971mishra@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 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Vrindmadhaw athwa Siddhyoga 23/82, Procedure details: For 7 days
Purva Karma – Snehan, Swedan after that
Pradhana Karma- administration of Matra Basti
Pashchata Karma- tapping of sole, buttocks, legs etc.
)
(1) Medicine Name: Bala Taila, Reference: Vrindmadhaw athwa Siddhyoga 23/82 , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Mulabandha | (Procedure Reference: Hatha yoga pradipika Chapter 3 verses 61-63, Procedure details: sitting in padmasana, then focus on breathing and move attention to pelvic region. inhale deeply and retain breath. slowly contract genitourinary and anal openings. hold the lock but do not strain. hold the bandha as long as person can retain their breath. at the end relax genitourinary and anal openings. this is one round of mulbandha. repeat this cycle for 10 times twice a day. )
| | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Feeling of something coming our per vagina
2 micturition disturbances
3 bowel disturbances
4 Backache
5 Dragging pain in pelvis
6 symptoms with 1st and 2nd degree utero vaginal prolapse
|
|
| ExclusionCriteria |
| Details |
1 age below 30 and above 60 years
2 pregnancy
3 history of psychotic diseases
4 anal fissure and haemorrhoids
5 PID and other STD
6 congenital anomalies leading to prolapse
7 3rd and 4th degree uterine prolapse |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
decrease in symptoms
feeling of mass coming per vagina |
before intervention and every month after intervention for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in backache or dragging pain in pelvis |
duration of 4 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
04/06/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pinkcity11011@gmail.com].
- For how long will this data be available start date provided 27-05-2024 and end date provided 27-09-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Women’s health is prime concern of
medical fraternity. Therefore, modern as well as traditional medical science
put major focus on women’s health. Indian
women have high mortality rates, particularly during childhood and in their
reproductive years. The health of Indian women is intrinsically linked to their
status in society. Anatomically and physiologically reproductive system of
women is different from male. Women have certain anatomical changes in uterus
due to pregnancy, childbirth and in menopausal phase, make her more prone to
Uterine Prolapse / Utero-vaginal Prolapse. a.
Clinical Study
Type
–Randomized Intervention Trial
Total
150 patients aged 30 to 60 years from the O.P.D. / I.P.D., Department of Prasuti
Tantra, S.S. Hospital, BHU, Varanasi (UP) will be screened for Yonibhransha (1st and 2nd degree
utero-vaginal prolapse) by the consultant [co-supervisor] then
will be allowed for registration. The consent of (1st and 2nd
degree Utero-vaginal prolapse) patients will be obtained for participation in
the study then they will be registered on a predesigned proforma. These
registered patients will be divided into three groups randomly by using random
number generation in an excel sheet. The
three groups will be as follows: -
Group
A (50 Cases) –This group will have ( 1st
and 2nd degree Utero-vaginal prolapse) patients who will be advised with practicing Mulbandha standard technique.
Group
B (50 Cases) – This group will have ( 1st
and 2nd degree Utero-vaginal prolapse) who will be advised with Matra Basti (Bala Taila) along with Pichu Dharan (Panchavalkala
Taila).
Group
C (50 Cases) -
Control Group will be treated with Placebo.
Placebo capsule (1BD)
|