| CTRI Number |
CTRI/2024/10/074622 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Phytochemical & clinical evaluation of the effect of Sunthi Kwath along with Castor oil on Dard yukta Mahavari. |
|
Scientific Title of Study
|
A Phytochemical & clinical evaluation of the effect of sunthi kwath along with castor oil on 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 |
Dr Nupur Gupta |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan prasad Awasthi Goverment Ayurved college raipur chhattisgarh 492001 |
| Address |
Department of Dravyaguna vigyana Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9074169431 |
| Fax |
|
| Email |
nupur211995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Singh |
| Designation |
Lecture Dravyaguna vigyan |
| Affiliation |
Shri Narayan prasad Awasthi Goverment Ayurved college raipur chhattisgarh 492001 |
| Address |
Special clinic Dravyaguna department OPD 02 Ground floor Shri Khudadad dungaji Goverment Ayurved Hospital opposite NIT GE road raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827085023 |
| Fax |
|
| Email |
vdrajeshsingh12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Kumar Agrawal |
| Designation |
Reader Dravyaguna Vigyan |
| Affiliation |
Shri Narayan prasad Awasthi Goverment Ayurved college raipur chhattisgarh 492001 |
| Address |
Special clinic Dravyaguna department OPD 01 Ground floor Shri Khudadad dungaji Goverment Ayurved Hospital opposite NIT GE road raipur chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9074683151 |
| Fax |
|
| Email |
dr.akhil1287@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyagun vigyan Shri Narayan Prasad Awasthi Goverment Ayurved College GE Road opposite NIT Raipur Chhattisgarh 492001 |
|
|
Primary Sponsor
|
| Name |
Shri khudadad dungaji goverment ayurved hospital |
| Address |
Shri Narayan Prasad Awasthi Goverment Ayurved College GE Road opposite NIT Raipur Chhattisgarh 492001 |
| Type of Sponsor |
Government medical 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 NUPUR GUPTA |
Shri Khudadad Dungaji Goverment Ayurved college hospital raipur Chhattisgarh |
OPD NO 16 ward no 2 Department of Prasutitantra & Strirog Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur GE Road opposite NIT Raipur Chhattisgarh 492001
Raipur
CHHATTISGARH |
9074169431
nupur211995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri Narayan Prasad Awasthi Goverment Ayurved college Raipur Chattisgarh |
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 | Drug | Classical | | (1) Medicine Name: Sunthi kwatha, Reference: cakradatta 25/6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sunthi kwath with castor oil, Reference: cakradatta 25/6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Cakra.25 adhyay slok no-06 page no-166 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Painful menstruation, H/O painful menstruation for at least 3 consecutive menstrual cycles, with scanty or normal amount of bleeding, Patient with regular menstrual cycles (21-35 days),No history of pregnancy |
|
| ExclusionCriteria |
| Details |
1.female patients with endometriosis, uterine fibroid, endometrial polyp, PCOD, chronic pelvic infection, pelvic adhesion, adenomyosis .
2.parients having any systemic illness like DM ,HTN, uncontrolled thyroid, other endocrinopathies.
3. H/O malignancy of pelvic organs.
4. patients on prolonged medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of menstrual pain in
primary dysmenorrhea. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the life style of patient. |
2 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| 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="5"
Days="29" |
|
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
|
Dysmenorrhea
is a severe uterine pain during menstruation. It is classified into two,
primary and secondary Dysmenorrhea. Primary Dysmenorrhea has no organic cause, start
usually during teenage years and coincides with the onset of ovulatory cycles.
Secondary Dysmenorrhea usually arises in later reproduction age and usually is
the result of pelvic pathology. Primary
Dysmenorrhea usually has regular menstrual cycles with symptoms beginning just
prior to menstruation. Primary Dysmenorrhea is related to myometrial
contractions induced by prostaglandins originating in secretory endometrium,
thereby causing endometrial ischemia and pain. The pain is with suprapubic
cramping and may be accompanied by lumbosacral backache, pain radiating down
the anterior thigh. For
the present study Primary Dysmenorrhea cases only will be includes. Prevalence
of Primary Dysmenorrhea in india range between 50 – 87.8%. The condition of
dysmenorrhea is explained in ayurvedic literature in terms of Kukshi shool, kastartava, vatala yonivyapad, udavartini yonivyapad. According to ayurved
increase vata dosha in the body is major causative factor for Dysmenorrhea.
Drug which have Shula Prashamana , Vatanulomana and Vatashamaka properties are beneficial. |