| CTRI Number |
CTRI/2023/05/052213 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Palashudumbaradi Lepam followed by Kapikacchu mooldhavanam along with yogic practices in Pelvic Organ Prolapse |
|
Scientific Title of Study
|
A clinical Study to Evaluate the efficacy of Palashudumbaradi Lepam followed by Kapikacchu Mooldhavanam along with yogic practices in Yonibhramsa and Vivrita yoni |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Shukla |
| Designation |
HOD PTSR Department |
| Affiliation |
Rajiv Gandhi Govt Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Shukla |
| Designation |
HOD PTSR Department |
| Affiliation |
Rajiv Gandhi Govt Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Katna |
| Designation |
PG scholar PTSR Department |
| Affiliation |
Rajiv Gandhi Govt Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
9418308914 |
| Fax |
|
| Email |
Katna.shivani2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy ,RGGPGAC PAPROLA ,HP Research institute in ISM jogindernagar,district Mandi ,HP |
|
|
Primary Sponsor
|
| Name |
principal |
| Address |
RGGPGAC and Hospital,Paprola,kangra |
| Type of Sponsor |
Research institution |
|
|
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 |
| shivani katna |
RGGPGAC college and hospital |
paprola,
Kangra
HIMACHAL PRADESH |
9418308914
katna.shivani2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human) |
Approved |
|
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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 | - | yoni dhAvana, योनि धावन | (Procedure Reference: Yogratnakar 8, Procedure details: Twice a day two hours after lepam)
(1) Medicine Name: Kapikacchu Mool kwath, Reference: Yogratnakar 8, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 250(ml), Frequency: bd, Duration: 3 Months | | 2 | Intervention Arm | Procedure | - | lepa, लेप Pradhan Karma | (Procedure Reference: Bhaishajya ratnavali 67/21, Procedure details: Twice a day for 8 days for 3 months per vaginal )
(1) Medicine Name: Palashudumbaradi lepam, Reference: Bhaishajya ratnavali 67/21, Route: Vaginal, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 3 Months | | 3 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yogic exercises plus procedures in intervention group , Pathya/Apathya:, Pathya:, Apathya: |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients having sign and symptoms of 1st and 2nd degree uterine prolapse
2.Patient having signs and symptoms of cystocele and rectocele
3.Patients with complaints of difficulty in micturition,incomplete emptying of bladder,dyspareunia
4.Patient having signs and symptoms of laxity of perineum |
|
| ExclusionCriteria |
| Details |
Patient having 3rd degree or complete uterine prolapse.
patient having PID,cervicitis,fibroid in uterus,endometriosis
Patient with evidence of malignancy or cervical intra-epithelium neoplasia or cervical carcinoma
Patient with history of untreated sexually transmitted diseases or known to be HIV positive |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reposition the prolapsed uterus and vagina into its original position |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in associated features like difficulty in micturition,dyspareunia,backache,vaginal discharges |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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)
|
Not Yet Recruiting |
| 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
|
Research report will be soon published after the completion of trial.40 patients fulfilling inclusion and exclusion criterion will be randomly selected from the OPD and IPD of department of PTSR,RGPGAC and Hospital ,Paprola.Patients will be divided randomly into 2 groups,,Group I and Group II each with 20 patients.Group I will be given application of Palashudumbaradi Lepam followed by Kappikacchu mooldhavan and group II will be made to do yogic exercises along with Palashudumbaradi Lepam and Kapikachu mooldhawan .Results will be assessed on the basis of subjective and objective assessment criterias. |