| CTRI Number |
CTRI/2025/07/091825 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Erand Taila Yonipichu In Chronic Pelvic Inflammatory Disease. |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL OF ERAND TAILA YONIPICHU IN THE
MANAGEMENT OF PARIPLUTA YONIVYAPAD WITH SPECIAL REFERENCE TO CHRONIC
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 |
DrPallavi Dinkar Kamthe |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
OPD NO 5 Prasutitantra and Streerog Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9766512837 |
| Fax |
|
| Email |
janakidinkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSachin Jagannath Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
OPD NO 5 Prasutitantra and Streerog Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
Sachinpatil5190@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSachin Jagannath Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
OPD NO 5 Prasutitantra and Streerog Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
Sachinpatil5190@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College & Hospital PG Institute & Research Centre Urun Islampur Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr.Pallavi Dinkar Kamthe |
| Address |
LRP Ayurvedic Medical College & Hospital PG Institute & Research Centre Urun Islampur Sangli 415409 Maharashtra India |
| 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 |
| Pallavi Dinkar Kamthe |
LRP Ayurvedic Medical College And Research Institute Urun Islampur Sangli |
OPD No. 5 Department Of Streerog And Prasutitantra LRP Ayurvedic Medical College And Research Institute Urun Islampur
Sangli
MAHARASHTRA |
9766512837
janakidinkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee LRP Ayurvedic Medical College and Hospital and PTC and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchawalkal Taila, Reference: Bhavprakash Nighantu Vatadi Varga , Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 7 Days After Cessation Of Menses For 2 Consecutive Cycles | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erand Taila, Reference: Gad Nigrah 6/6/16, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 7 Days After Cessation Of Menses For 2 Consecutive Cycles |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Only Married women in between Age group of 21-50 yrs.
2. Patient having specific symptoms of chronic pelvic inflammatory disease like
chronic pain in abdomen, previous history of acute pelvic inflammatory disease
malaise associated with lower abdominal pain and tenderness. |
|
| ExclusionCriteria |
| Details |
1.Patients having Malignant or Benign tumor, Polyp, Fibroid, Endometriosis,
Tubo-Ovarian Mass, Adenomyosis etc.
2. Pregnant women
3.Unmarried women
4.Known case of Diabetes mellitus,HTN ,Asthma
5. Patients with pelvic inflammatory disease when seen associated with prolapsed
uterus.
6 Known case of HIV ,VDRL. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease In Sign And Symptom Of Yonidaha,Yonigat Strav,Katishoola,Ruja |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Decrease In Sign And Symptom Of Yonidaha,Yonigat Strav,Katishool,Ruja |
2 Month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/08/2025 |
| 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="6"
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
|
Paripluta yonivyapad has been chosen for the present study which is seen in married women of reproductive age (21-50yrs). Need has always been felt to develop certain ayurvedic treatment modalities for the management of Paripluta Yonivyapad (Chronic Pelvic inflammatory Disease) which could be safe, effective, readily available, cost effective, without any side effects in comparison to the therapeutic procedures of different systems of medicine. Ayurveda has holistic approach towards the treatment of Paripluta Yonivyapad with their backgrounds an effort is made to evaluate the efficacy of Erand taila yoni pichu in series of patients suffering from Paripluta Yonivyapad (Chronic Pelvic inflammatory Disease). The Erand taila is having properties as vata kapha shamak,Madhur vipak,kashay rasa because of these properties it help to overcome the symptoms of Paripluta Yonivyapad by increasing local immunity and prevent recurrence of symptoms in patients |