| CTRI Number |
CTRI/2024/12/078248 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the combined effect of Karanjadi churna with Baladi kashaya in patients with Primary dysmenorrhoea. |
|
Scientific Title of Study
|
Clinical study on the efficacy of Karanjadi churna as add-on therapy with Baladi kashaya in Primary dysmenorrhoea |
| 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 Shahinamole S |
| Designation |
Professor and HOD |
| Affiliation |
Government ayurveda college |
| Address |
Government ayurveda medical college
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government ayurveda medical college
Dhanwantari nagar
Puthiyakavu
Tripunitbura
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahinamole S |
| Designation |
Professor and HOD |
| Affiliation |
Government ayurveda college |
| Address |
Government ayurveda medical college
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government ayurveda medical college
Dhanwantari nagar
Puthiyakavu
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahinamole S |
| Designation |
Professor and HOD |
| Affiliation |
Government ayurveda college |
| Address |
Government ayurveda medical college
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government ayurveda medical college
Dhanwantari nagar
Puthiyakavu
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda medical college
Tripunithura
Ernakulam
Kerala Pin code 682301
India |
|
|
Primary Sponsor
|
| Name |
Shebeena PV |
| Address |
PG Scholar
Department of Prasuti tantra and Streeroga
Government ayurveda college Tripunithura |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shebeena PV |
Government ayurveda medical college |
Prasuti tantra and Streeroga department
Ground floor
Dhanwantari nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA |
8129580573
shebeenapv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Commity for Ethics in Research(Institutional Review Board) Govt.Ayurveda College,Tripunithura,Kochi,Kerala-682301 |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanjadi churna, Reference: Yogaratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Baladi kashaya), Additional Information: for 3 consecutive months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Baladi kashaya, Reference: Chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: for 3 consecutive months |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subjects with Primary dysmenorrhoea, with regular periods coming to OPD of Prasuti tantra and Streeroga, Govt. Ayurveda College Hospital, Tripunithura.
Unmarried and married nullipara within the age group of 15-35 years. |
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with pelvic pathology.
Subjects with irregular menstruation. Known case of DUB. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the mean score value of lower abdominal pain during menstruation assessed by
Verbal Descriptive Scale and Visual Analogue Scale. |
0th and 4th day of 3 consecutive menstrual cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in associated symptoms such as nausea, vomiting,diarrhoea, low back ache, headache and giddiness as per Verbal Descriptive Scale. |
0th and 4th day of 3 consecutive menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
27/12/2024 |
| 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 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
|
Dysmenorrhoea is defined as painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. The prevalence of Primary dysmenorrhoea was 80.9%. Most of the females with primary dysmenorrhoea described their menstrual pain as moderate to severe, which affected their daily activities and studying ability significantly. It is of two types: primary dysmenorrhoea and secondary dysmenorrhoea. Primary dysmenorrhoea is one where there is no identifiable pelvic pathology. Here the pain begins a few hours before or just with the onset of menstruation. In secondary, menstrual pain is associated with some pelvic pathologies. Dysmenorrhoea can be compared with Udavartha/Udavarthini/Udavrtta, one among 20 yonirogas mentioned in Ayurveda classics. As per Acharya Charaka, Udavarthini is due to varadhan (suppression of natural urges), which will cause aggravation of vayu which in turn leads to pain because of the tendency of menstrual blood to move in upward direction. Baladi kashaya mentioned in Chakradutta-Sulaprakarana and Karanjadi churna mentioned in Yogaratnakara-Sula chikitsa are selected for the study. Ingredients of Baladi kashaya are having anulomana, sulahara, arthavajanana, balya, rasayana, deepana, bhedaneeya, vatakaphahara. Karanjadi choorna contains Karanja, Sauvarchala, Nagara and Ramata/Hingu. Most of these drugs are having vatakaphahara, vata anulomana, sulaghna and vibandhaghna properties.The study design is Randomized Controlled Trial with sample size of 18 in each group. Female subjects of age group 15-35 years with primary dysmenorrhoea attending OPD of Prasuti tantra and Streeroga, Govt. Ayurveda College Hospital, Tripunithura will be selected for the study as per inclusion and exclusion criteria. Participants are randomly divided into Group A and Group B using the chit method. Group A will be given 2g Karanjadi churna with 48 ml Baladi kashaya twice daily before food and Group B will be given Baladi kashaya alone twice daily before food for 7 days ie, 5 days prior to next menstruation and first 2 days of menstruation for 3 consecutive periods. Assessment for pain and associated symptoms will be done on 0th day, 4th day of 1st, 2nd and 3rd cycles and same procedure will be repeated in the follow up period after 1 month. Verbal Descriptive Scale and Visual Analogue Scale will be taken for the assessment of pain, and the associated symptoms will be assessed using Verbal descriptive scale. Results will be statistically analysed afterthe study through appropriate test and conclusion will be drawn. |