| CTRI Number |
CTRI/2025/06/088802 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of madhukadi vati and panchavalkala kwath prakshalana to manage pelvic inflammatory disease |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of madhukadi vati and panchavalkala kwath prakshalana in the management of paripluta yonivyapada with special reference to pelvic inflammatory disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVishakha Masram |
| Designation |
MS(Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9370569148 |
| Fax |
0 |
| Email |
vishakhamasram1910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrReshma Devi |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9935010178 |
| Fax |
0 |
| Email |
dr.reshma1411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVishakha Masram |
| Designation |
MS(Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9370569148 |
| Fax |
0 |
| Email |
vishakhamasram1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrVishakha Masram |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India
Lucknow
UTTAR PRADESH |
09370569148
0
vishakhamasram1910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Committee State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: PARIPLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhukadi vati, Reference: Harita samhita madhyamsthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Dose-2tab BD (500mg each) daily for 2 months | | 2 | Comparator Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charak Samhita Chikitsa sthan 30, Procedure details: Yoni Prakshalana is a deep cleansing of the vagina under aseptic precaution.
Duration 7 days after cessation of menses for 2 consecutive cycles
Position of the patient Dorsal lithotomy
Quantity 500ml of Kwath
Procedure
Purvakarma
1.The patient is advised to empty her bladder & rectum.
2.The patient is advised to lie down in the dorsal lithotomy position.
Pradhankarma:
1.The douching pan is filled with lukewarm Panchavalkala Kwath. A 4 - 5 feet rubber pipe is connected with douching pan & a nozzle is attached which is inserted in the vagina and washed out for 5-10 minutes.
Paschatkarma:
1.The patient is asked to sit in a squatting position and advised mild straining, so the remaining Kwath is removed.
2.The vulva is dried by a gauge piece.)
(1) Medicine Name: Madhukadi vati, Reference: Harita samhita madhyamsthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Married women between the age group of 21 to 45 years
2 Patient suffering from abnormal vaginal discharge more than 3 consecutive cycles
3 Cardinal symptoms of Paripluta Yonivyapada
Lower abdomen pain
Low back pain.
Dyspareunia
Patient willing for trial |
|
| ExclusionCriteria |
| Details |
1 Pregnant women
2 Unmarried
3 Patient suffering from any systemic disease like tuberculosis hypertension or diabetes
4 Patient having specific pathology of the genital tract ie benign or malignant tumor
5 Severe or chronic ill health conditions
6 Acute PID and peritonitis tubo ovarian abscess |
|
|
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.To evaluate the efficacy of Madhukadi vati and Panchavalkala Kwath prakshalana in the management of Paripluta yonivyapada.
2.To compare the efficacy of Madhukadi vati and Madhukadi vati with Panchavalkala Kwath prakshalana in the management of Paripluta yonivyapada.
|
after 30 days
after 30 days
after 30 days of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Conceptual study of Paripluta yonivyapada and its modern correlation.
2.To find out the safe and potent drug for Paripluta yonivyapada
3.Decrease in abnormal vaginal discharges
4.Reduction in pelvic pain
5.To evaluate any adverse effects associated with treatment. |
after 30 days
after 30 days
after 30 days of trial |
|
|
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 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomised, comparative clinical study phase 2 parallel group trial. Comparing the efficacy of Madhukadi vati and Panchavalkala kwath Prakshalana in cases of Paripluta Yonivyapad for 2 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Paripluta Yonivyapad will be randomly selected from OPD/IPD of State Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group A- In this group patients will be treated with Madhukadi vati orally 2 tabs BD (500mg each) with lukewarm water after meal for the period of 2 months. Group B- In this group patients will be treated with Madhukadi vati orally 2 tabs BD (500mg each) with lukewarm water after meal for the period of 2 months along with Panchavalkala kwath Prakshalana locally in the dose of 500ml for the period of 7 days after cessation of menses.Follow up period every 30 days during the treatment and 30 days after the completion of trial. |