| CTRI Number |
CTRI/2021/04/033096 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of dysmenorrhoea with hingvadi churna vati and dashmultrivritadi basti |
|
Scientific Title of Study
|
A comparative clinical study of hingvadi churna vati and dashmultrivritadi basti in the management of krichhartva with special reference to dysmenorrhoea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Rani |
| Designation |
MS student |
| Affiliation |
RGGPG Ayurvedic College,paprola |
| Address |
RGGPG Ayurvedic College Paprola,Kangra
Teh-Baijnath Distt-Kangra
RGGPG Ayurvedic College,Paprola
Teh-Baijnath Distt-Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8894356189 |
| Fax |
|
| Email |
nehaprashar51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSeema Shukla |
| Designation |
HOD and Reader ,deptt of prasuti tantra avum stree roga |
| Affiliation |
RGGPG Ayurvedic College,Paprola |
| Address |
RGGPG Ayurvedic College,Paprola
Teh-Baijnath Distt-Kangra
RGGPG Ayurvedic College,Paprola
Teh-Baijnath Distt-Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018272730 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSeema Shukla |
| Designation |
HOD and Reader ,deptt of prasuti tantra avum stree roga |
| Affiliation |
RGGPG Ayurvedic College,Paprola |
| Address |
RGGPG Ayurvedic College,Paprola
Teh-Baijnath Distt-Kangra
RGGPG Ayurvedic College,Paprola
Teh-Baijnath Distt-Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018272730 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy ,RGGPG Ayurvedic College,Paprola
Teh-Baijnath Diatt-Kangra
Pin code-176115
RIISM Joginder Nagar (H.P.) |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola Distt-Kangra
H.P. |
| 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 |
| Neha Rani |
Rggpg Ayurvedic College,Paprola |
Rggpg Ayurvedic College,Paprola
Teh-Baijnath
Distt-Kangra
Kangra
HIMACHAL PRADESH |
8894356189
nehaprashar51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Hingwadi churna vati" |
15 patient of krichhartava will be treated by Hingwadi churna vati orally 2gm BD a day with lukewarm water ,start 10days before menses and 5 days during mense
|
| Comparator Agent |
Dashmooltrivritaadi basti |
15 patient of krichhartva will be treated with Dashmooltrivritaadi basti which will be given after clearance of menses in yog krama for three consecutive cycle |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.patient willing for the trial
2.patient between the age group of 16-45 years
3.patients coming with chief complaint of krichhartva during mensturation. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for trial
2.patient with uterine and pelvic pathology like big fibriod > 5 cm ,endocervical polyp,CA cervix etc.
3. Patient suffering from maligancy and other chronic and systemic disorders specially those that are mention as ashadhaya vayadi as per clinical text of ayurveda will be exculded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in the symptoms of Dysmenorrohea |
3 months during the treatment period and at follow up of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Painless menstruation and feeling of gernal wellbeing |
Painless menstruation after 3 monthsof trial |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2021 |
| 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="0"
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
|
Patients will be selected from opd and ipd of RGGPG Ayu.College and Hospital,Paprola. Two groups of 15patients each,will be registered and one group will be given Hingwadi churna vati orally and in other group,Dashmooltrivrit yoga basti will be adminstered.Assessment of the effect of treatment will be done on the basis of subjective and objective signs and symptoms of krichhrartava w.s.r.to dysmenorrhoea on the basis of grading and scoring system. |