| CTRI Number |
CTRI/2025/07/090813 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study on the Effect of Ayurvedic Vaginal Oil Treatment for Managing Pelvic Inflammatory Disease in Women. |
|
Scientific Title of Study
|
A Comparative Clinical Study on The Efficacy of Dhatakyadi Tail Yoni Pichu and Panchavalkaladi Tail Yoni Pichu in the management of Paripluta Yonivyapad w. s. r. 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 |
Dr Astha Jain |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centreand |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third Floor room number 1.Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8982871549 |
| Fax |
|
| Email |
Jain.astha0407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandraprabha Pinge |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya pradesh |
| Address |
Department of Prasuti Tantra Evum Stri Roga Third Floor room number 1 Mansarovar Ayurvedic Medical College Hospital and research Centre Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9420248023 |
| Fax |
|
| Email |
drchandraprabha0611@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandraprabha Pinge |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya pradesh |
| Address |
Department of Prasuti Tantra Evum Stri Roga Third Floor room number 1 Mansarovar Ayurvedic Medical College Hospital and research Centre Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9420248023 |
| Fax |
|
| Email |
drchandraprabha0611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya pradesh Pincode 462042 India |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhop |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third Floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya pradesh |
| 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 |
| DrAstha Jain |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
Room number 1 Third Floor Department of Prasuti Tantra Evum Stri Roga ,Mansarovar
Ayurvedic Medical College Hospital and Research Centre Bhopal
Bhopal
MADHYA PRADESH |
8982871549
Jain.astha0407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mansarovar Ayurvedic Medical College and Hospital l |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: ICD-1, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni picu | (Procedure Reference: Classical, Procedure details: Dhatakyadi Tail will be given pervaginal after 6 th day of menstruation for 14 days)
(1) Medicine Name: Dhatakyadi Tail, Reference: Charak chikitsa, Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Classical, Procedure details: Panchavalkaladi Tail will be given pervaginal after 6 th day of menstruation for 14 days. )
(1) Medicine Name: Panchavalkaladi Tail, Reference: Charak Chikitsa, Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
The Patients having classical symptoms of Paripluta Yoni vyapad as per the classical references will be selected
The Patient above 18 years of age and under 50 years
Patient willing for trial and ready to give consent
|
|
| ExclusionCriteria |
| Details |
Patients giving history of recent delivery or abortion
Patients suffering from Cancer
Patients having systemic and other disorder like Diabetes TB Hypertension etc
Pregnant and Lactating mother
Patients during menstruation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Dhatakyadi Tail Yoni Pichu and Panchavalkaladi Tail Yoni Pichu in the management of Paripluta Yonivyapad, as measured by clinical or subjective scale that are Symptom severity score pain score vaginal discharge score over a period of 28 days
|
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CBC
Urine routine and microscopic
USG Pelvis |
28 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="0"
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
|
The prevalance of Pelvic Inflammatory Disease in women of reproductive age is 3 -10 %Quality of life of women with these disorders is compromised. Paripluta Yonivyapad is the common gynecological problem affecting her day to day activities. This leads to other disease like Chronic Pelvic pain and Infertility. Dhatakyadi Tail and Panchavalkaladi Tail Yoni Pichu formulation has been selected to study the efficacy of both drug in the management of Paripluta Yonivyapad. The aim of this study is so establish an cost effective harmless Ayurvedic medication for the treatment of Paripluta Yonivyapad. |