| CTRI Number |
CTRI/2022/07/044092 [Registered on: 18/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trail of Ayurvedic therapy in management of painful menses |
|
Scientific Title of Study
|
A randomised controlled trial to evaluate the efficacy of Hinguwadi gutika and Rajahpravartini vati in the Management of Udavarta Yonivyapad W.S.R. to 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 PREETI KUKRELE BAGDI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STRIROGA
NATIONAL INSTITUTE OF AYURVEDA,
JORAWARSINGH GATE
jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9770313129 |
| Fax |
|
| Email |
dr.preetibagdi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K BHARATHI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STRIROGA,
NATIONAL INSTITUTE OF AYURVEDA,
JORAWARSINGH GATE
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR K BHARATHI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STRIROGA,
NATIONAL INSTITUTE OF AYURVEDA,
JORAWARSINGH GATE
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
|
Source of Monetary or Material Support
|
| PHARMACY OF NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
NATIONAL INSTITUTE OF AYURVEDA (DEEMED TO BE UNIVERSITY), JORAWARSINGH GATE, JAIPUR, RAJASTHAN |
| Type of Sponsor |
Other [GOVERNMENT AYURVEDA 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 PREETI KUKRELE BAGDI |
NIA ( Deemed to be University) OPD and IPD, Jaipur |
NATIONAL INSTITUTE OF AYURVEDA (DEEMED TO BE UNIVERSITY) , JORAWARSINGH GATE
Jaipur
RAJASTHAN |
9770313129
dr.preetibagdi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajahpravartini vati, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hingwadi gutika, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. PATIENTS WITH CHIEF COMPLAINT OF PAIN DURING MENSES ALONG WITH ASSOCIATED SYMPTOMS.
2. PATIENTS WHO HAVE MENSTRUAL PAIN SCORE MORE THAN GRADE I ACCORDING TO VERBAL MULTIDIMENSIONAL SCORING SYSTEM (VMSS).
3. PATIENTS WHO HAD REGULAR MENSTRAL CYCLES OF 23-35 DAYS IN THE LAST 3 MONTHS.
4. PATIENT IN AGE GROUP OF 18 TO 30 YEARS
5. PATIENTS WITH H/O USING ANALGESICS DURING MENSES.
6. PATIENT WILLING TO GIVE VOLUNTARY INFORMED CONSENT FOR THE STUDY. |
|
| ExclusionCriteria |
| Details |
The patient suffering from any severe systemic, or autoimmune disorders, specially those who are mentioned as Asadhya vyadhi as per clinical text of Ayurveda will be excluded.
Subjects having organic pathology of uterus and adnexa like Fibroid uterus,carcinoma of endometrium, endometriosis etc.
1 having pelvic inflammatory disease or 2 chronic leucorrhoea.
3 Patients who vaccinated for covid19 with in past three month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. NRS – Scale: Numeric Rating Scale for Dysmenorrhoea |
60 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. VMSS scale: Verbal Multidimensional Scoring System |
60 DAYS |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menstruation is normal vaginal bleeding that happens as part of woman’s monthly menstrual cycle. Dysmenorrhea is the condition of painful menstrual periods or menstrual discharge associated with pain. It is seen commonly in teenage girls and in young women. Dysmenorrhea is seen with mild to moderate intensity, and in up to 20% of women it may be severe enough to interfere with daily activities. The pain is most often manifests as menstrual cramps, like a throbbing pain or cramping pain in lower abdomen. It may also be associated with low-back pain, pain in thighs, leg pains, nausea, vomiting, diarrhea etc. It is commonly divided into primary dysmenorrhea and secondary dysmenorrhea. In Primary dysmenorrhoea pain occurs without any organic pathology and initial onset takes place usually 6-12 months after menarche, when ovulatory cycles are established. Pain duration is commonly 8 to 72 hours and is usually associated with the onset of menstrual flow. NULL HYPOTHESIS [H0] There is no difference in Oral administration of Hinguvadi gutika and Rajahpravartani vati in managing the Udavarta Yonivyapad with special reference to Primary dysmenorrhea. ALTERNATIVE HYPOTHESIS [H1] There is difference between in Hinguvadi gutika and Rajahpravartavi vati in managing the Udavarta Yonivyapad with special reference to Primary dysmenorrhea. |