| CTRI Number |
CTRI/2018/02/012167 [Registered on: 26/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL STUDY OF PURGATION IN MIGRAINE BY TRIVRUT KALKA WITH KANJEE |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE ROLE OF VIRECHANA KARMA BY TRIVRUT KALKA WITH KANJEE IN THE MANAGEMENT OF ARDHAVBHEDAKA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana |
| Designation |
MD Scholar |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurveda and hospital Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9718816120 |
| Fax |
|
| Email |
dr.archanachoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minaj Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurveda Dhankawadi Pune
Department of Panchakarma
Pune
MAHARASHTRA
411043
India |
| Phone |
9960321732 |
| Fax |
|
| Email |
drminaj362@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra Vedpathak |
| Designation |
head of the department |
| Affiliation |
Bharati Ayurveda College and Hospital |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurveda Dhankawadi Pune
Department of Panchakarma
Pune
MAHARASHTRA
411043
India |
| Phone |
7030309088 |
| Fax |
|
| Email |
drsurendravedpathak50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma Bharati Vidyapeeth deemed to be university college of Ayurveda dhankawadi pune 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical Foundation Ayurveda Hospital Pune |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurveda Dhankawadi Pune
Department of Panchakarma |
| 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 Archana |
Bharati Vidyapeeth Ayurved Hospital |
BVDU college of Ayurveda Dhankawadi Pune Maharashtra
Department of Panchakarma
Pune
MAHARASHTRA |
9718816120
dr.archanachoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| bvdu college of ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients comes under inclusive criteria of the study , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
Not applicable |
| Intervention |
trivrut kalka with kanjee |
Route of administration of the drug is oral and amount of Trivrut Kalka is 8O gm and Kanjee is 50 ml and duration of therapy is 8 days with follow up of 1 month |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of Ardhavbhedaka Vyadhi included like Manyaativedana Bhruativedana Sankhaativedana Karnaativedana Akshiativedana Ardhalalata ativedana |
|
| ExclusionCriteria |
| Details |
patients who are unable to convey their problem excluded
patients above 60 years and below 16 years excluded
patients who are contraindicated to do Virechan or in any serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients relieve from all sign and symptoms of Ardhavbhedaka like pain in cervical and temporal region and in eye or ear in 1 month |
1 month duration of Assessment of results |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| observed all sign and symptoms of Ardhavbhedaka for 1 month |
therapy duration is of 7 days, and complete treatment 1 month |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/11/2017 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Publication in Underreview |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ardhavbhedaka is the most common found disease in india in which vitiated vata singly accompanied by Kapha seizes the half of the head and then produces severe pain like cutting and churning in half of the Manya,Bhru ,shankh, karna ,Netra and lalata region .Due to these symptoms the patient becomes restless .Though the disease ,Ardhavbhedaka is not life threatening it makes worried the patient and distrubing the routine.It affects approximately 16% of Population, gender wise it afflicts approximately 15% of women and 6% of men. Virechana is one of the Panchakarma procedure useful for Ardhavbhedaka Vyadhi.Though Virechan is Pitta doshahara Chikitsa . Trivruta kalka with Kanjee is used as treatment drug in the study as trivrut is considered as Sheshtha virechaka dravya and also it acts on Tridosha. Kanjee is Amla Rasatmak and having Teekshna Property and also acts as bhedi. Patients with the age group of either gender from 16 to 60 year with sign and symptoms of Ardhavbhedaka are included in the study and patients who are contraindicated for the Virechana are excluded from the study and also who have serious illness are excluded. Trivrutmula kalka of 1 to 4 tola and kanjee about 20 ml is given to the patient
Treatment Schedule: | 1 | No. of patients | 30 | | 2 | Age group | 16- 60 yrs | | 3 | Virechak Dravyas | Trivrutmool Kalka +Kanjee | | 4 | Dose | Till Samyak Virechan Lakshana appear | | 5 | Time | 9:00 am | | 6 | Poorvakarma | Deepan, Pachan- if Samavastha, then Jeerak Churna with luke warm water till Niramvastha will be given. Shodhananga Snehpana with Cow’s ghrit for 3/5/7 days Arohana Kram till Samyak Snigdha Lakshanas were produced Bahyasnehan will be done with Tila Taila (after Samyaka Snighdha lakshana) Swedana-Sarvanga Bashpa Peti Swedana (last three days) 3 days of Vishram kaal Drava, Ushna, Laghu, Amla Aahar in Vishram kaal. | | 7 | Pradhankarma | Virechan Procedure | | 8 | Pashchatkarma | Samsarjana Krama and Pariharya Vishay | | 9 | Samsarjana Karma | 3/5/7 days according to type of Shuddhi (Pravara/Madhyama/Avara) | | 10 | Assessment days | 1st assessment will be done before starting of treatment 2nd assessment will be done After Virechan Procedure | | 11 | Follow ups | 1st F/U at the end of Samsarjana Krama, 2nd and 3rd F/Ups on 15th and 30th day after Virechan Karma respectively. | |