| CTRI Number |
CTRI/2024/04/065596 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| 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
|
A Clinical Trial To Study The Effect Of Lodhra, Tumbiphala Kalka And Lajjalu Kalka As Yonipichu In Pelvic Organ Prolapse |
|
Scientific Title of Study
|
An Open Label Double Arm Comparative Clinical Study To Evaluate The Effect Of Lodhra, Tumbiphala Kalka And Lajjalu Kalka As Yonipichu. |
| 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 SHILPY SHUKLA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
OPD No 209 Department Of Prasooti Tantra And Stree Roga
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9741251256 |
| Fax |
|
| Email |
shuklashilpy428@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUPAMA V |
| Designation |
PROFESSOR |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
OPD No 209 Department Of Prasooti Tantra And Stree Roga
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHILPY SHUKLA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre |
| Address |
OPD No 209 Department Of Prasooti Tantra And Stree Roga
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9741251256 |
| Fax |
|
| Email |
shuklashilpy428@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore Karnataka India 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Shilpy Shukla |
| Address |
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore Karnataka India 560104 |
| Type of Sponsor |
Other [self] |
|
|
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 Shilpy Shukla |
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre |
OPD No 209 Department Of Prasooti Tantra And Stree Roga
Sri Kalabyraveswara Swamy Ayurvedic Medical College Hospital And Research Centre Bangalore 560104
Bangalore
KARNATAKA |
9741251256
shuklashilpy428@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SKAMCH And RC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N819||Female genital prolapse, unspecified. Ayurveda Condition: PRASRAMSINI/PRASRAVINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Bhaishajya Ratnavali Adhyaya 7, Procedure details: Lajjalu Kalka will be used for yonipichu in pelvic organ prolapse. Duration is 60 days.)
(1) Medicine Name: Lajjalu Kalka , Reference: Bhaishajya Ratnavali Adhyaya 7, Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 3(g), Frequency: od, Duration: 60 Days | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Bhaishajya Ratnavali Adhyaya 7, Procedure details: Lodhra Tumbiphala Kalka will be used for yonipichu in pelvic organ prolapse. Duration is 60 days )
(1) Medicine Name: Lodhra Tumbiphala Kalka, Reference: Bhaishajya Ratnavali Adhyaya 7, Route: Vaginal, Dosage Form: Kalka/ Paste, Dose: 3(g), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female Patients between 35 and 60 years. (both years
inclusive)
Uterine Prolapse First And Second Degree
Mild To Moderate Rectocele
Mild To Moderate Cystocele |
|
| ExclusionCriteria |
| Details |
Carcinoma of Cervix
Any sexually transmitted disease
Urethrocele
Procedentia
Any systemic illness which interferes with the course of treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment based on subjective parameters Like Mass per vagina along with or without these symptoms as follows- Uterine incontinence, Backache, Dyspareunia, Fecal incontinence, Stress incontinence. |
Efficacy of treatment will be assessed on the
subjective parameters at baseline and the end of
30 days till 60 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment based on Objective parameters.
1 Prolapse assessed by POP quantification
2 Tenderness assessment of cervical motion tenderness & abdominal tenderness by palpation with visual analog scale |
Effect of treatment will be assessed by objective parameters at baseline & the end of 30 days till 60 days |
|
|
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)
|
20/04/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Pelvic organ prolapse is one of the clinical conditions seen in day today gynecological practice specifically amongst the parous women due to weakness of the structural support. These factors may be anatomical or clinical. The main presenting complaints include mass per vagina,urinary incontinence, overactive bladder, fecal incontinence. Out of many Sthanika chikitsa yoni pichu advised in conditions like pelvic organ prolapse. Vaginal wall and adjacent tissues are extremely vascular and this facilitates absorption of drugs through vagina. anatomically backward position of vagina helps in self retaining of drugs for a longer duration. Hence, Yoni pichu has chosen for study . It leaves a scope to find out a remedy which would offer cure of the disease, free from complications and economically better. Hence, yonipichu with lodra and tumbhi phala is choosen, which is economically better, with less complications and will help in strengthening the uterine and vaginal walls. It can also prevent first and second degree uterine prolapse to progress to third degree. The drug Lodhra is kashya and tikta rasa ,sheeta veerya and katu vipaka and Tumbiphala are Tikta Rasa ,katu Vipaka in nature and Mamsa vivardhana and lajjalu is tikta ,kashya rasa ,sheeta virya and it is yoniroganasat it helps for Yonidrudhikarana here.Thus there is need to know its efficacy in pelvic organ prolapse. In first group tumbiphala and lodhra kalka as yonipichu will be used . In Second group lajjalu kalka as yonipichu will be used . |