| CTRI Number |
CTRI/2025/05/087521 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study Comparing Two Ayurvedic Oral Drugs When Used With Vaginal Wash Locally In Management of Upper Reproductive Tract Infections |
|
Scientific Title of Study
|
Randomized comparative clinical study to evaluate the efficacy of guduchyadi ghrita and go-ghrita along with panchvalkala kwatha yoni prakshalana in paripluta yonivyapad W.S.R 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 |
Dr Cheshta Gautam |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College, Udaipur, India |
| Address |
P.G. Department of Prasuti Tantra Evum Striroga, Madan Mohan Malviya Govt. Ayurveda College, Ambamata, Udaipur Rajasthan, India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976511374 |
| Fax |
|
| Email |
cheshtagautam52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diksha Khathuria |
| Designation |
Lecturer |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College, Udaipur, India |
| Address |
P.G. Department of Prasuti Tantra Evum Striroga, Madan Mohan Malviya Govt. Ayurveda College, Ambamata, Udaipur Rajasthan, India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413727680 |
| Fax |
|
| Email |
diksha.khathuria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Khathuria |
| Designation |
Lecturer |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College, Udaipur, India |
| Address |
P.G. Department of Prasuti Tantra Evum Striroga, Madan Mohan Malviya Govt. Ayurveda College, Ambamata, Udaipur Rajasthan, India
RAJASTHAN
313001
India |
| Phone |
9413727680 |
| Fax |
|
| Email |
diksha.khathuria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurveda college Udaipur, Rajasthan 313001, India |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt. Ayurveda college Udaipur, Rajasthan 313001, India |
| Address |
Madan Mohan Malviya Govt. Ayurveda college Rada ji circle, Ambamata, Udaipur, 313001, Rajasthan, India
|
| 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 |
| Dr Cheshta Gautam |
Madan Mohan Malviya Govt. Ayurveda College, Udaipur |
OPD no. 05, Prasuti tantra evum striroga department, Rajvaidya Prem Shankar Sharma Rajkeeya Ayurveda Chikitsalaya, Ambamata and O.P.D.No. 06,Prasuti Tantra Evum Striroga Department, Rajkeeya Ayurveda Chikitsalaya Moti Chouhatta Udaipur, Rajasthan
Udaipur
RAJASTHAN |
7976511374
cheshtagautam52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Madan Mohan Malviya Govt. Ayurveda college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N739||Female pelvic inflammatory disease, unspecified. Ayurveda Condition: PARIPLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Ghrita, Reference: Vangsen Strirogadhikar 114/115, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Go-ghrita, Reference: Charak Viman 1/14 , Sushruta Sutra 45/97, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 3 | Intervention Arm | Procedure | - | Yoni Prakshalana योनि प्रक्षालन | (Procedure Reference: Ashtanga Sangraha Uttarsthana 39/49, Procedure details: Medicated Decoction Applied Through The Vaginal Route Under Aseptic Precaution The Vagina, Vaginal Passage And Mouth of Uterus Were Washed Enema Pot Used For Handling The Yoni Prakshalana, After The Procedure The Vulva Was Dried With Cotton. After Completion of The Procedure Patient Is
Asked To Sit On Bed Pan And To Cough Hence The Remnant Medication Will Come Out / Duration 7 Days After Cessation of Menstruation For One Cycle)
(1) Medicine Name: Panchvalkala Kwatha, Reference: Charak Chikitsa 30/62, Ashtanga Sangraha Uttarsthana 39/49, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: od, Duration: 7 Days | | 4 | Comparator Arm | Procedure | - | Yoni Prakshalana योनि प्रक्षालन | (Procedure Reference: Ashtanga Sangraha Uttarsthana 39/49, Procedure details: Medicated Decoction Applied Through The Vaginal Route Under Aseptic Precaution The Vagina, Vaginal Passage And Mouth of Uterus Were Washed Enema Pot Used For Handling The Yoni Prakshalana, After The Procedure The Vulva Was Dried With Cotton. After Completion of The Procedure Patient Is
Asked To Sit On Bed Pan And To Cough Hence The Remnant Medication Will Come Out / Duration 7 Days After Cessation of Menstruation For One Cycle)
(1) Medicine Name: Panchvalkala Kwatha, Reference: Charak Chikitsa 30/62, Ashtanga Sangraha Uttarsthana 39/49, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Married females.
2. Patients aged between 21 years to 50 years who are sexually or reproductively active.
3. Diagnosed cases of PID.
4. Patients suffering from lower abdominal pain, abnormal vaginal discharge, low backache, painful coitus, menstrual disorders etc.
5. Patients willing to go through trial |
|
| ExclusionCriteria |
| Details |
1. Pregnant females.
2. Patients with peritonitis.
3. Patients with Tubercular tubo-ovarian mass.
4. Patients with Appendicitis.
5. Patients with Septic abortion.
6. Patients who require surgical interventions in cases like pelvic abscess.
7. Patients with reproductive malignancies.
8. Patients with Ovarian tumour & Ovarian cysts.
9. Patient having Pelvic endometriosis.
10. Other systemic illness like Uncontrolled DM, Active T.B., Uncontrolled hypertension, Known cases of TORCH infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the symptoms of paripluta yonivyapad w.r.s pelvic inflammatory disease like pelvic pain, dyspareunia, abnormal vaginal discharge, fever, dysuria etc. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in all other investigatory parameters (USG-Pelvic region, ESR etc) |
30 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 |
|
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="3"
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 clinical study aims to evaluate and compare the efficacy of Guduchyadi Ghrita and Go-Ghrita, both administered orally along with Panchvalkala Kwatha yoni prakshalana, in the management of Paripluta Yonivyapad, a condition correlated with Pelvic Inflammatory Disease (PID). The primary objective is to assess changes in key symptoms such as pelvic pain, dyspareunia, abnormal vaginal discharge, fever, and dysuria between the two treatment groups. Secondary objectives include a detailed study of the disease’s Ayurvedic and modern pathogenesis and the identification of any adverse drug reactions.
The study is a randomized, open-label, comparative clinical trial conducted over 30 days on 60 married women aged 21 to 50 years, diagnosed with PID. Participants are divided equally into two groups. Group A receives Guduchyadi Ghrita orally (5 ml with milk twice daily) along with Panchvalkala Kwatha for yoni prakshalana (10 gm per vagina for 7 days post-menstruation), while Group B receives Go-Ghrita with the same external procedure. Patients are recruited from the OPD and IPD of Madan Mohan Malviya Government Ayurved College, Udaipur, and written consent is obtained prior to participation.
Inclusion criteria include sexually active women with symptoms like lower abdominal pain, abnormal discharge, backache, dyspareunia, and menstrual irregularities, while exclusion criteria rule out pregnant women and those with severe systemic or gynecological conditions requiring surgery or with malignancies. Randomization is done using a computer-generated sequence and allocation is concealed using SNOSE method.
Assessment is based on subjective symptom scoring and objective findings including laboratory investigations such as CBC, ESR, RBS, LFT, RFT, urine analysis, Pap smear, and pelvic USG, both before and after treatment. Follow-up is conducted every 15 days to monitor progress and compliance. The trial aims to determine the safety and efficacy of these Ayurvedic interventions in managing PID through both traditional and modern diagnostic parameters. |