| CTRI Number |
CTRI/2026/04/109328 [Registered on: 24/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for period pain |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Effect of Ajmoda Churna with and without Yavachurnadi Lepa in Management of Udavartini Yonivyapad W.S.R. Primary Dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Manoj Yadav |
| Designation |
PG Scholar |
| Affiliation |
Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
| Address |
Department of PTSR ,Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot
Bagalkot
KARNATAKA
587125
India |
| Phone |
8452864274 |
| Fax |
|
| Email |
nehay4396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Basavaraj Nadagouda |
| Designation |
Professor and HOD |
| Affiliation |
Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
| Address |
Department of PTSR ,Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot
Bagalkot
KARNATAKA
587125
India |
| Phone |
9845378026 |
| Fax |
|
| Email |
nadagoudashobha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobha Basavaraj Nadagouda |
| Designation |
Professor and HOD |
| Affiliation |
Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
| Address |
Department of PTSR ,Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot
Bagalkot
KARNATAKA
587125
India |
| Phone |
9845378026 |
| Fax |
|
| Email |
nadagoudashobha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
|
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Primary Sponsor
|
| Name |
Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
| Address |
Shri Vijay mahantesh Ayurvedic Medical College and PG research centre, Ilkal, dist- Bagalkot |
| 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 |
| Dr Neha Manoj Yadav |
Shri Vijay mahantesh Ayurvedic Medical College, PG research centre,R.P kardi hospital ilkal |
OPD No. 10 dept of prasuti tantra and stree roga department , shri vijaya mahantesh Ayurvedic Medical college and P. G research center and R.P kardi hospital , ilkal, district- Bagalkot, karnataka
Bagalkot
KARNATAKA |
8452864274
nehay4396@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Svmamc/ethical/2025 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 | Drug | Classical | | (1) Medicine Name: ajmoda churna, Reference: dhanvantari nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 23 Days, anupAna/sahapAna: Yes(details: koushna jal), Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: sharamdhar samhita, Procedure details: Preparation of lepa
1) Mix yava churna & yavakshar powder in equal quantities
2) after preparing the yavachurnadi mixer before appliying fresly mix with freshly prepared takra
Purva Karma (Pre-procedure)
1) Patient lies in supine position (Uttana Shayana)
2) Abdomen exposed (lower abdomen/pelvic region)
Pradhana Karma (Main Procedure)
1) Apply prepared lepa over:Lower abdomen (below the umbilicus) till Suprapubic region
2) Thickness: ~ 0.5–1 cm layer
3) Direction: clockwise circular application
3) Retain for 20–30 minutes or till semi-dry
4) Can be repeated 1–2 times daily during pain phase
Paschat Karma (Post-procedure)
Remove lepa gently
Clean with lukewarm water
Patient advised rest and avoid cold exposure)
(1) Medicine Name: Yavachurnadi lepa, Reference: bhaisajya ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Duration: 5 Days(2) Medicine Name: ajmoda churna , Reference: dhanvantari nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 23 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling the diagnostic criteria
Age between 18-35 years
Painful menstruation for at least 2 consecutive cycles
Patients with regular menstrual cycles
|
|
| ExclusionCriteria |
| Details |
Congenital Anomalies leading to dysmenorrhea.
Cases of Secondary dysmenorhea with pelvic pathology – fibroid of uterus, ovarian cyst, endometriosis, Endometrial polyp, etc., adenomyosis, and any organ lesion ( benign and malignant growth of the reproductive tract )
Patient having any chronic diseases like tuberculosis, HIV
Patient with intrauterine Contraceptive Device/hormonal therapy endocrine disorders like thyroid abnormalities and PCOD
Women on oral contraceptive pills
Lactating mother.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intensity of the lower abdomen pain should be reduced during menses |
after taking treatment for 2 consecutive cycles i.e after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| menstrual flow should be proper & regular |
after 2 consecutive menstural cycles |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2026 |
| 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 Yet Recruiting |
| 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
|
Due to Westernised living patterns, there are many irregularities seen in menstruation with associated symptoms, one of which is dysmenorrhea. mainly primary dysmenorrhea. In Ayurveda, it is considered with Udavartini yonivyapada, where vata prakopa is there , so to pacifies vata and treat the main cause, ajmoda churna is taken and for local action, yavachurnadi lepa has choosen so to look if the combined action is more effective or both are equal, hence the topic is selected as A Randomised Comparative Clinical Study to evaluate the effect of Ajmoda churna with and without yavachurnadi lepa in the management of udavartini Yonivyapada w.s.r primary Dysmenorrhea |