| CTRI Number |
CTRI/2023/05/052663 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
15/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of utero-vaginal prolapse with Kapikachhu Mula Kwatha and Laghu Phala Ghrita |
|
Scientific Title of Study
|
Comparative clinical study in the management of Prasramsini Yoni Vyapad w.s.r to utero-vaginal prolapse with Kapikachhu Mula Kwatha and Laghu Phala Ghrita |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swagatika Padhan |
| Designation |
P.G Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya, Puri |
| Address |
P.G Department of P.T.S.R., Gopabandhu Ayurveda Mahavidyalaya, VIP Road, Puri
Puri
ORISSA
752002
India |
| Phone |
9668865173 |
| Fax |
|
| Email |
swagatikapadhan06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sudeshna Meher |
| Designation |
Professor and H.O.D |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya, Puri |
| Address |
P.G Department of P.T.S.R., Gopabandhu Ayurveda Mahavidyalaya, VIP Road, Puri
Puri
ORISSA
752002
India |
| Phone |
9438585095 |
| Fax |
|
| Email |
drsmeher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sudeshna Meher |
| Designation |
Professor and H.O.D |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya, Puri |
| Address |
P.G Department of P.T.S.R., Gopabandhu Ayurveda Mahavidyalaya, VIP Road, Puri
Puri
ORISSA
752002
India |
| Phone |
9438585095 |
| Fax |
|
| Email |
drsmeher@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya, Puri |
|
|
Primary Sponsor
|
| Name |
Dr Swagatika Padhan |
| Address |
P.G Department of P.T.S.R.,Gopabandhu Ayurveda Mahavidyalaya, Puri |
| 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 Swagatika Padhan |
Gopabandhu Ayurveda Mahavidyalaya, Puri |
P.G Department of P.T.S.R, Gopabandhu Ayurveda Mahavidyalaya, Puri
Puri
ORISSA |
9668865173
swagatikapadhan06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gopabandhu Ayurveda Mahavidyalaya and Hospital, Puri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N812||Incomplete uterovaginal prolapse. Ayurveda Condition: PRASRAMSINI/PRASRAVINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghu Phala Ghrita, Reference: Sarangadhar Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Usna jala), Additional Information: -In a group of 20 patients Laghu Phala Ghrita is administered orally for 3 months | | 2 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Bhava Prakash, Procedure details: In a group of 20 patients 500 ml of Kapikachhu mula Kwatha for yoni prakshalana for 14 days after cessation of menses for 3 consecutive cycles)
(1) Medicine Name: Kapikachhu Mula Kwatha, Reference: Bhava Prakash, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 42 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Married women
First and second degree uterovaginal prolapse |
|
| ExclusionCriteria |
| Details |
Unmarried women
Complete uterovaginal prolapse
Congenital abnormalities of genital tract
Benign and malignant growthin genital tract
History of pelvic and vaginal surgery
Pregnancy
PID |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To manage the degree of prolapse in Prasramsini Yonivyapad |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To control the symptoms |
1 month, 2 months, 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is expected that the present clinical study will bring out a standard and effective treatment in the management of prasramsini yonivyapad w.s.r. to uterovaginal prolapse. |