| CTRI Number |
CTRI/2025/01/079772 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL TRIAL COMPARING THE EFFECTIVENESS OF VIPARITHALAJJALLU KSHEERAPAKA AND ASHOKA KSHEERAPAKA IN TREATING ASRIGDARA |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the efficacy of Viparithalajjalu Ksheerapaka and Ashoka Ksheerapaka in Asrigdara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJinu sekhars |
| Designation |
PhD scholar |
| Affiliation |
|
| Address |
post graduate department of Prasuti Tantra Evum shree roga Swaminarayan ayurvedic college Ahmedabad-mehsana Highway At And po saji Ta Kalol Dist
Gandhinagar
Gujarat
382725
India
unnithans ayurveda hospital and research center near A C road perunnai changanacherry
Kottayam
KERALA
382725
India |
| Phone |
7907941016 |
| Fax |
|
| Email |
jinuaswin17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jamunadevi Chandramouli |
| Designation |
Professor |
| Affiliation |
|
| Address |
post graduate department of Prasuti Tantra Evum shree roga Swaminarayan ayurvedic college Ahmedabad-mehsana Highway At And po saji Ta Kalol Dist
Gandhinagar
Gujarat
382725
India
post graduate department of Prasuti Tantra Evum shree roga Swaminarayan ayurvedic college Ahmedabad-mehsana Highway At And po saji Ta Kalol Dist
Gandhinagar
Gujarat
382725
India
Gandhinagar
GUJARAT
382725
India |
| Phone |
9535881003 |
| Fax |
|
| Email |
jamunadevichandramouli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jinu sekharS |
| Designation |
PhD scholar |
| Affiliation |
|
| Address |
post graduate department of Prasuti Tantra Evum shree roga Swaminarayan ayurvedic college Ahmedabad-mehsana Highway At And po saji Ta Kalol Dist
Gandhinagar
Gujarat
382725
India
unnithans ayurveda hospital and Research Center near A C road perunnai chaganacherry
Kottayam
KERALA
382725
India |
| Phone |
7907941016 |
| Fax |
|
| Email |
jinuaswin17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Unnithans Ayurveda Hospital and Research Center
near AC road
perunnai
Chananassery
Kerala
India
686102 |
|
|
Primary Sponsor
|
| Name |
DrJinsekharS |
| Address |
Unnithans Ayurveda Hospital and Research Center
near AC road
perunnai
Changanassery
Kerala
India
686102 |
| 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 |
| Dr Rathi B Unnithan |
unnithans Ayurveda Hospital and Research center |
unnithans Ayurveda Hospital And Research Center
near AC road Perunnai
Changanacherry
kottayam
Kerala
India
686102
Kottayam
KERALA |
9074343015
unnithansayurvedahospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, swaminarayan university kalol |
Approved |
| SREE NARAYANA INSTITUTE OF AYUVEDIC STUDIES AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
viparithalajjalu ksheerapaka
ashoka ksheerapaka |
both groups will be given 40 ml twice daily before food for 3 cycles .for excessive bleeding the medicine should start from the 2nd day of menstruation to continuous days .for prolonged bleeding medicine should start from 4 the day of menstruation 5 continuous days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Cardinal symptoms of Asrigdara with a minimum
of 2 months history.
2. Patients with the age group of 20 years to
40years.
3. The number of pads used daily decides the
quantity of menstrual blood.
4. The pads used during the period were of the
same company.
5. PCOD (prolonged bleeding and excessive
bleeding).
6. Patients having Hb% above 7gm/dL
|
|
| ExclusionCriteria |
| Details |
bleeding due to benign and malignant growth
coagulation disorders
bleeding from the site other than the uterus
lactation period
patients having Hb% below 7gm/dl |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of Viparithalajjalu ksheerapaka and Ashoka Ksheerapaka in the management of Asrigdara. |
both the groups will be administered with ksheerapa 40 ml twice daily before food for 3 cycles for excessive bleeding from 2nd day to 5 continuous days and prolonged bleeding starting from 4 the day of menstruation to 5 continuous days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the property and effect of viparithalajjalu ksheerapaka and Ashoka ksheerapaka in Asrigdara
|
7 months |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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)
|
17/03/2025 |
| 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="4"
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
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIPARITHALAJJALU KSHEERAPAKA AND ASHOKA KSHEERAPAKA IN ASRIGDARA
NEED FOR THE STUDY Abnormal uterine bleeding is a common but complicated clinical presentation. it included both dysfunctional uterine bleeding and bleeding due to structural causes. Arigdara is an excessive or prolonged flow of blood occurring in the menstrual or intermenstrual period as per manuscripts of Ayurveda .it shows a close resemblance to AUB and DUB. So many oral preparations are found effective in clinical practices but effectiveness is not proven statistically. Acharyas have mentioned that the treatment of rakhathapithahara can be adopted in asrigdara . the drug of viparithalajjalau ksheerpaka has the property of rakhathapithahara .in yogamritham Asrigdara chapter,sidhaprayoga mentioned about viparithalaljjalu prayoga,clinically found effective and statically not proven , the present study was undertaken to analyze statically. MATERIALS AND METHOD A separate case proforma will be prepared with history-taking, physical signs and symptoms, lab investigation, and USG findings mentioned by allied sciences. The parameters of signs symptoms and investigation will be scored based on standard methods and will be assessed statistically. Designs of study: A single-blind clinical study of two groups of control and trials consisting of 114 subjects.
|