| CTRI Number |
CTRI/2025/12/098547 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy of Yoga Basti along with Pippalyadi Yoga orally in Paripluta Yoni Vyapad w.s.r to P.I.D. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Yoga Basti (Eranda) along with Pippalyadi Yoga orally in Paripluta Yoni Vyapad w.s.r to P.I.D. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof. Seema Shukla |
| Designation |
Retired Professor |
| Affiliation |
Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P., 176115 |
| Address |
Awasthi Ayurvedic Medical College and Hospital, Nalagarh, Solan, H.P. 174101
Solan
HIMACHAL PRADESH
174101
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Soni Kapil |
| Designation |
HOD, Prasuti Tantra evum Stree Roga |
| Affiliation |
Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P., 176115 |
| Address |
P.G. Dept of Prasuti Tantra evum Stree Roga, Room No. 203, Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P., 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Sharma |
| Designation |
P.G. Scholar, Prasuti Tantra evum Stree Roga |
| Affiliation |
Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P., 176115 |
| Address |
P.G. dept of Prasuti Tantra evum Stree Roga, Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P., 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418008833 |
| Fax |
|
| Email |
priyankaacharya.com@gmail.com |
|
|
Source of Monetary or Material Support
|
| HP Charak pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and
Hospital Paprola Distt Kangra, HP, Research Institute in ISM Jogindernagar, Distt Mandi HP |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
Dept of Ayurveda, Himachal Pradesh Secretariat, Shimla-171002, H.P. 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 Seema Shukla |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP |
OPD and IPD
Department of Prasuti
Tantra evum Stree
Roga,RGGPG Ayurvedic
College and Hospital
Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418008833
drseemanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) (Rajiv Gandhi Govt. P.G. Ayu. College and Hospital, Paprola, Kangra, H.P. |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi yoga, Reference: Charak Samhita Chikitsasthana 30/54-55, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -ghee), Additional Information: - | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita Siddhisthana 3/38-41, Procedure details: 1 procedure per day for 8 days in a month, for 2 consecutive months))
(1) Medicine Name: Eranda Mooladi Niruha Basti and Eranda Taila Anuvasana Basti, Reference: Charak Samhita Siddhisthana 3/38-41, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients willing by giving consent and able to participate in the trial.
2. Patient between age group of 20-40 years.
3. Clinically diagnosed patients which fell under symptomatic criteria of Paripluta Yoni Vyapad (PID).
4. Married patients.
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Age - Less than 20 years & more than 40 years.
3. Genital malignancies.
4. Diabetic and severely anemic patients
5. HIV Infection, Gonorrhea, Syphilis, Genital Herpes, Genital warts.
6. Unmarried
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| overall assessment will be seen in improvement in subjective and objective criteria |
once in a day for 8 days for a month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall assessment will be seen in improvement in subjective & objective criteria |
once in a day for 8 days for a month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/12/2025 |
| 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
|
Research paper will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criteria will be randomly selected from the OPD and IPD of department of Prasuti Tantra evum Stree Roga, RGGPG Ayu. College and Hospital, Paprola, Kangra. Patients will be divided into 2 groups with 15 patients each. 1. Patient will be managed by Yoga basti alone. 2. Patient will be managed by Yoga basti along with oral drug. Duration of trial is for 8 days a month for 2 consecutive cycles, after clearance of menses. Results will be based on subjective and objective criteria. |