| CTRI Number |
CTRI/2025/07/089919 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study The Effect of Karanjadi Churna In Pain In Abdomen During Menses |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Study The Shulaghna Effect Of Karanjadi Churna In The Management of Udavartini Yonivyapada With Special Reference To Primary Dysmenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHumera mohammed haji shaikh |
| Designation |
Pg resident |
| Affiliation |
SMBT Ayurveda college and hospital dhamangaon nashik |
| Address |
Department of prasuti tantra evum stri roga SMBT Ayurveda college and hospital dhamangaon nashik maharashtra 422403 india
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8788104299 |
| Fax |
|
| Email |
shaikhtahir940@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Sureshchandra Gholap |
| Designation |
Professor |
| Affiliation |
SMBT Ayurveda college and hospital dhamangao nashik n |
| Address |
Department of prasuti tantra evum stri roga SMBT Ayurveda college and hospital dhamangaon nashik maharashtra 422403 india Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820304881 |
| Fax |
|
| Email |
drSameer.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Humera mohammed haji shaikh |
| Designation |
Pg resident |
| Affiliation |
SMBT Ayurveda college and hospital dhamangao nashik n |
| Address |
Department of prasuti tantra evum stri roga SMBT Ayurveda college and hospital dhamangaon nashik maharashtra 422403 india Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9766310638 |
| Fax |
|
| Email |
shaikhtahir940@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Ayurveda college and hospital dhamangaon nashik maharashtra India 422403 |
|
|
Primary Sponsor
|
| Name |
DrHumera mohammed haji shaikh |
| Address |
SMBT Ayurveda college and hospital dhamangaon nashik maharashtra India 422403 |
| 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 Humera mohammed haji shaikh |
SMBT Ayurveda College and Hospital dhamangaon igatpuri Nashik 422403 |
OPD no 5 Department of Prasuti tantra evum stri roga
Nashik
MAHARASHTRA |
8788104299
shaikhtahir940@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurveda college and hospital |
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 (Non Ayurveda) | | - | Mefenamic acid | Mefenamic acid -500mg
Route - oral
Dose - 500 mg
With normal water
After meal | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanjadi Churna , Reference: Yogaratnakar,uttarardha , Shulaghna adhayay,shloka 10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: -- |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1) patient suffering from the symptoms like unbearable pain in lower abdomen during menstrual cycles 2) school and college going girls between age 13 to 30 yrs 3) patient having regular menstrual cycle with normal amount of menstrual flow(normal 2-3 pads/day) |
|
| ExclusionCriteria |
| Details |
1) patient with secondary dysmenorrhea
2) patient with IUCD
3) patient taking contraceptive pills and hormonal therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Udavartini Yonivyapada after giving Karanjadi Churna |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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
|
Prevalence rate of primary dysmenorrhoea is 70.2%. Primary dysmenorrhoea is confined to adolescents. The incidence of primary dysmenorrhoea of sufficient magnitude to incapicitation is 15-20%. In modern science first line choice therapy for primary dysmenorrhoea is NSAIDs. They are highly effective, but have their own side effects if used for longer period. The primary treatment for udavartini yonivyapada is vatashaman. Karanjadi churna has properties like vatanuloman, vatashaman, shoolprashaman. As previously no study has been done on Karanjadi churna in Udavartini yonivyapada, so it will be helpful in female between age group 13 to 30years having sign and symptoms of primary dysmenorrhoea such as painful menstruation, suprapubic and lumbosacral pain. Written informed consent will be taken to ensure compliance and transperancy in research process. The sample size calculated 35 in each group by Daniel formula1999. Simple random sampling technique will be used. Total 70 number of patients will be divided into two groups as group A(trial group) and group B(control group). Karanjadi churna to group A and Mefenamic acid to group B.All SOP of churna will be followed throughout the clinical trial. Observation will be done after menstrual cycle. Result will be drawn on the basis of assessment criteria statistical Discussion will be done on the basis of observation and result obtained during treatment.Summary will be drawn, and thesis will be summarised with the help of statistical analysis.Conclusion will be drawn. |