| CTRI Number |
CTRI/2025/08/092432 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Panchajeeraka Guda in reducing symptoms of Udavartini Yonivyapada. |
|
Scientific Title of Study
|
Add on effect of Panchajeeraka Guda in the management of Udavartini Yonivyapada with special reference to Primary Dysmenorrhea -A Randomized Controlled Clinical Trial |
| 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 Isha |
| Designation |
PG Scholar |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre |
| Address |
Room No. 23 Department of Stree Roga and Prasuti Tantra KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre
Belgaum
KARNATAKA
590003
India |
| Phone |
8901029656 |
| Fax |
|
| Email |
isha.kaushik7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Hubli |
| Designation |
Associate Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre |
| Address |
Room No. 23 Department of Stree Roga and Prasuti Tantra KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre
Belgaum
KARNATAKA
590003
India |
| Phone |
8970216099 |
| Fax |
|
| Email |
drboradevi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Hubli |
| Designation |
Associate Professor |
| Affiliation |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre |
| Address |
Room No. 23 Department of Stree Roga and Prasuti Tantra KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre
Belgaum
KARNATAKA
590003
India |
| Phone |
8970216099 |
| Fax |
|
| Email |
drboradevi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Isha |
| Address |
PG Scholar Department of Stree Roga and Prasuti Tantra KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre Belagavi Karnataka 590003 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 |
| Dr Isha |
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre |
Room no. 23 Department of Stree Roga and Prasuti Tantra KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies and Research Centre Belagavi Karnataka 590003 India
Belgaum
KARNATAKA |
08901029656
isha.kaushik7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak Chikitsa 30/41, Procedure details: Tila Taila Matra Basti 60ml/day for 7 days after cessation of menstruation in each of 2 consecutive cycles )
(1) Medicine Name: Tila Taila, Reference: Sushrutra Sutra 45/118, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak Chikitsa 30/41, Procedure details: Tila Taila Matra Basti 60ml/day for 7 days after cessation of menstruation in each of 2 consecutive cycles )
(1) Medicine Name: Tila Taila, Reference: Sushrutra Sutra 45/118, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchajeeraka Guda, Reference: Chakradatta Stri Roga Chikitsa 45-50, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -warm milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients fulfilling the diagnostic criteria.
2) 15 to 25 years of age.
3) Painful menstruation for at least 3 consecutive cycles.
4) Regular menstrual cycles ranging from 21 to 35 days.
5) With average amount of menstrual flow.
6) Basti Yogya.
7) Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Diagnosed patients of secondary dysmenorrhea or with pelvic pathology
(Eg-Endometriosis, fibroids, pelvic inflammatory disease etc.)
2) With irregular menstrual cycles.
3) Patients with systemic diseases like Diabetes, Hypertension, Thyroid dysfunction,
Malignancy etc.
4) HIV, VDRL, HBsAG positive Patients.
5) Women using intrauterine contraceptive devices.
6) Lactating women. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant reduction in pain intensity associated with Udavartini Yonivyapada in the
group receiving Panchajeeraka Guda and Tila Taila Matra Basti as compared to the
Group receiving Tila Taila Matra Basti Alone. |
0 th day, 2nd Month Menstrual cycle, 3rd Month Menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The Combined Therapy (Panchajeeraka Guda & Tila Taila Matra Basti) will Show a
greater reduction in associated Symptoms Compared to Tila Taila Matra Basti.
2. The therapy will be safe, Well tolerated & may suggest a synergistic effect of oral and
rectal routes in managing Udavartini Yonivyapada |
0th day, 2nd Month Menstrual cycle, 3rd Month Menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Primary Dysmenorrhea is a common illness in reproductive age. It is one of the most frequent cause of pelvic pain. It significantly affects the quality of life, such as limitation of daily activities and psychological stress, and is a major cause of school and work absenteeism.The prevalence of Primary Dysmenorrhea was estimated to be 70% with 34.7% complaining of severe Primary Dysmenorrhea. About 52.68% participants suffered from Primary Dysmenorrhea every month. Although modern science has approved drugs such as prostaglandin synthetase inhibitors, oral contraceptives, NSAIDs for the treatment, but they have limitations too. About 20% of women with Primary Dysmenorrhea are unresponsive to NSAIDs. Also these drugs have gastrointestinal side effects like nausea, constipation, vomiting, dry eyes, dry mouth and headache etc. Long term use may cause hepatotoxicity, nephrotoxicity and blurred vision etc. During menstruation, most experience gastrointestinal upsets as associated symptoms which in turn are increased by analgesics and anti-spasmodic drugs. Some drugs like selective COX-2 inhibitors have cardiovascular risks. Even the Combined oral contraceptives are unacceptable in young women and who want to conceive.This reveals a clinical gap and growing need for an approach that is effective, safe and sustainable.In Ayurvedic classics, it can be considered as Udavartini Yonivyapada and have various treatments like Matra Basti, Uttar Basti, Snehana, Swedana and oral medicines. Matra Basti has shown effectiveness in relieving symptoms, but for enhanced and sustained relief, there is a need to explore additional oral medications that can support Agni , regulate Vata and reduce Shoola. Considering this, Panchajeeraka Guda, mentioned in the context of Striroga Chikitsa in Chakradatta will be taken, considering its properties such as Vata Kaph hara, Vata anulomana, Deepana, Pachana, Shoolprashaman etc. Hence this study aims to evaluate the add on effect of Panchajeeraka Guda along with Tila Taila Matra Basti in the management of Udavartini Yonivyapada. |