| CTRI Number |
CTRI/2019/12/022512 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
23/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Dashamula saindhav sarpi-Oral and Nasya in Migraine |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Nasya(Dashamula Saindhav Sarpi) and oral(Dashamula Saindhav Sarpi) in Ardhavabhedaka W.S.R.to Migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GAURAV SINHA |
| Designation |
PG SCHOLAR |
| Affiliation |
VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE KHURJA UP |
| Address |
PG DEPTT OF PANCHKARMA VYDS AYURVEDIC COLLEGE DHARPA KHURJA UP India
VYDS DHARPA
KHURJA UP
203131
India
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9410356605 |
| Fax |
|
| Email |
abhikalp10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GIRISH NARAIN RAI |
| Designation |
PROFESSOR |
| Affiliation |
VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE KHURJA UP |
| Address |
PG DEPTT OF PANCHKARMA VYDS AYURVEDIC COLLEGE DHARPA KHURJA UP India
VYDS DHARPA
KHURJA UP
203131
India
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8218680766 |
| Fax |
|
| Email |
girishnarinrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GIRISH NARAIN RAI |
| Designation |
PROFESSOR |
| Affiliation |
VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE KHURJA UP |
| Address |
PG DEPTT OF PANCHKARMA VYDS AYURVEDIC COLLEGE DHARPA KHURJA UP India
VYDS DHARPA
KHURJA UP
203131
India
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8218680766 |
| Fax |
|
| Email |
girishnarinrai@gmail.com |
|
|
Source of Monetary or Material Support
|
| VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE AND Chaudhary Charan Singh University Meerut UP |
|
|
Primary Sponsor
|
| Name |
VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
DHARPA KHURJA UP
203131
India |
| Type of Sponsor |
Private 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 GIRISH NARAIN RAI |
VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE AND HOSPITAL |
DHARPA KHURJA UP 203131
Bulandshahar
UTTAR PRADESH |
8218680766
girishnarinrai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE OF VAIDYA YAGYA DUTT SHARMA AYURVED MAHAVIDYALAYA, KHURJA,DISTT.BULANDSHAHER U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DASHMULA SAINDHAV SARPI NASYA |
GROUP B STHANIKA ABHYANGA WITH MURCHITA TILA TAILA FOLLOWED BY SWEDANA THEN 6-8 DROPS DASHMULA SAINDHAV SARPI IN BOTH NOSTRILS IN MORNING EMPTY STOMACH THEN AFTER KAVALAM WITH SUKHOSHNA AMBU FOR 7DAYS REPEAT AFTER INTERVAL OF ONE WEEK.4 CYLES DONE I.E.DURATION 2MONTHS |
| Intervention |
DASHMULA SAINDHAV SARPI ORALLY |
GROUP A DOSE OF DASHMOOL SAINDHAV SARPI 1 PALA I.E.48 GRAMS IN TO TWO DIVIDED DOSE FOR 2 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Ardhavabhedaka (Migraine)according to Ayurvedic classics as well as Modern Parameters. |
|
| ExclusionCriteria |
| Details |
All patients contraindicated for Nasya,Sinusitis, hypertension, Severe depression or psychiatric disorders,Referred headache,Cluster headache,Trigeminal neuralgia,space occupying lesions. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in overall clinical signs and symptoms of Migraine based on the scale of International Headache Society |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analysis of effect of Dashmool saindhav sarpi in Migraine when administered nasally and orally |
2 months |
|
|
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)
|
24/12/2019 |
| 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
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a randomized two groups comprayive clinical trial to evaluatethe efficacy of classicallymentioned compound Dashmool saindhav sarpi in the management of Migraine.The study aimed to conduct the trial on 30 patients from OPD and IPD of VAIDYA YAGYA DUTT SHARMA AYURVEDIC COLLEGE AND HOSPITAL KHURJA. Study includes patients between 16 to 60 years.The drug administered as Nasya and Oral.In group A oral dose of Dashmool saindhav sarpi is one pala i.e.48 grams in to two divided dose for 2 months and in group B purva karma sthanik Abhyanga with murchita tila taila followed by Swedana.In Pradhan karma dose of nasya 6-8 drops in each nostrils followed by kavalam with sukhoshna Ambu for 7days repeat after one week.Such 4 cycles will be done duration for 2 months |