| CTRI Number |
CTRI/2023/02/050051 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of
Dashmool Grhit nasal drops & Pathyadi Kwath as syrup for oral intake in the
management of Ardhavbhedhak in general known as Migraine |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Dashmool Ghrita Nasya And Pathyadi Kwath In The Management Of Ardhavabhedak With Special Reference 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 |
Dr CHHAYA BAGHEL |
| Designation |
PG SCHOLAR |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Department of Panchkarma Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
A Centre for Excellence
Science Hills, Nehru Nagar Kolar Bypass Road,
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9174010213 |
| Fax |
|
| Email |
chhbghl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KAMINI SONI |
| Designation |
Reader |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Department of Panchkarma Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
A Centre for Excellence
Science Hills, Nehru Nagar Kolar Bypass Road,
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893362076 |
| Fax |
|
| Email |
Skamini382@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KAMINI SONI |
| Designation |
Reader |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
| Address |
Department of Panchkarma Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal
A Centre for Excellence
Science Hills, Nehru Nagar Kolar Bypass Road,
Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893362076 |
| Fax |
|
| Email |
Skamini382@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal-A Centre for Excellence
Science Hills, Nehru Nagar Kolar Bypass Road,
Bhopal 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Science Hills, Nehru Nagar - Kolar Bypass Road, Bhopal 462003 (M.P.) India |
| 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 CHHAYA BAGHEL |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal |
OPD Of Panchkarma Room no.2 & IPD Room no.125
Science Hills, Nehru Nagar Kolar Bypass Road,
Bhopal
Bhopal
MADHYA PRADESH |
9174010213
chhbghl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. Khushilal Sharma Govt.Ayurveda Institute,Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Kwath, Reference: Dr. Brahamahanand Tripathi, dipika commentary on sharangsdhara samhita, chaukhamba surbharati prakashan varanasi, madhyam khand, 2/146-147, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: same amount water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Kwath, Reference: Dr. Brahamahanand Tripathi, dipika commentary on sharangsdhara samhita, chaukhamba surbharati prakashan varanasi, madhyam khand, 2/146-147, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: same amount water), Additional Information: - | | 3 | Intervention Arm | Procedure | - | marSaH, मरà¥à¤¶ | (Procedure Reference: Astang Sangraha Sutra Sthana 29/18, Procedure details: Patient lie down in supine position with ease on Nasya table.Shira head should be Pralambita lowered hanging down and foots are slightly raised. -Head should not be excessively flexed or extended. - After covering the eyes with clean cotton cloth, the physician should raise the tip of the patient’s nose with his left thumb and with the right hand the lukewarm dashmooli ghrita Sukhoshna drug should be dropped in both the nostrils alternately in proper way)
(1) Medicine Name: Dashmooli Ghrita, Reference: Dr. Indradeva Tripathi Editor of Vaidhyaprabha Hindi Commentary of Chakradatta, Sanskrit Sanskrit Sansthan Varanasi ch.60 ver. 47, PP.374, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient’s between 20 to 60 year of age.
2.Patients with signs and symptoms of Ardhavabhedaka according to the Ayurveda Classics and modern text.
3.Disease chronicity in between 5 years.
4.Patient who fulfill under the Diagnostic criteria.
5.Patients those fit for Nasya Karma.
6.Patients who have given written consent to participate in the study.
7.Standard operative procedure of covid-19 pandemic will be adopted in all patients.
|
|
| ExclusionCriteria |
| Details |
1.Patient’s age below 20 years and above 60years.
2.Patients having referred pain in one half of head due to pathology of eye, ear, nose, throat, teeth will be excluded.
3.Patients having any other systemic pathology like renal failure, TB, heart disease etc will be excluded.
4.Patients having complicated migraine and other neurological disorders.
5.Head Injury
6.Childhood headache
7.Headache due to Benign/malignant, growth
8.Lactating and Pregnant women’s.
9.Patients who are not willing to written consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency,intensity,type of Headache |
21 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Headache has at least two of the following four characteristics:-
• Unilateral site.
• Pulsating quality
• Moderate or severe pain intensity
• Aggravation by routine physical activity (eg.walking or Climbing etc)
During headache at least one of the following Symptoms should be there:-
• Nausea /vomiting
• Photophobia /Phonophobia
• Headache attack lasting 4-72 hours
• Frequency of attacks 15 days per month |
7th Day
15thday
21st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/02/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM &
OBJECTIVES
To evaluate the efficacy
of Dashmool ghrit Nasya and Pathyadi Kwath in
management for Ardhavabhedaka (Migraine). To compares the effect
of only Pathyadi Kwath in the management of Ardhavabhedaka. STUDY DESIGN: This study will be designed as a Randomized
Controlled clinical study and the participants will be selected from simple
purposive sample technique. GROUPING: All the 40 patients of randomly selected will be
divided into 2 groups having 20patients in each group. GROUP - A: Intervention Group 20 patients of this group will be advised Dashmool ghrita Nasya and Pathyadi kwath 40 ml
twice a day for 21 days. GROUP - B: Control Group 20 patients of this group will be kept
with Pathyadi kwath 40 mltwice a day for 21 days. Study duration- 21 Days Follow up– 1 month CRITERIA FOR DIAGNOSIS : The diagnosis of the disease will be mainly
based on the signs and symptoms mentioned in Ayurveda texts and the modern texts. Headache has at least two of the following four
characteristics:- • Unilateral site. • Pulsating quality • Moderate or severe pain intensity • Aggravation by routine physical activity
(eg.walking or Climbing etc) During headache at least one of the following
Symptoms should be there:- • Nausea /vomiting • Photophobia /Phonophobia • Headache attack lasting 4-72 hours • Frequency of attacks 15 days per month. INVESTIGATION: • Complete Hemogram CRITERIA FOR ASSESMENT
The disease is assessed by graded according to
HIT- 6Tm. test (Headache impact test) Result will be assessed before and after
the treatment on the basis of gradations. TREATMENT REGIMEN
|
Procedure
|
Duration
|
Drug
|
DOSE
|
TIME
|
|
Marsh nasya
|
1-21 days
(7 Days +1 day rest + 7 days + 1 day rest + 5
days Nasya)
|
Dashmool Ghrita
|
8 bindu in each nostril
|
morning
|
|
Shaman Aushadh
|
1-21 days
|
Pathyadi Kwath
|
40 ml Twice a day
|
Before meal
|
HYPOTHESES NULL HYPOTHESIS - H0 : Group A (Dashmool ghrita Nasya and Pathyadi Kwath )
and group B Pathyadi Kwathare equally effective in the
management of Ardhavavbhedaka (Migraine). ALTERNATE HYPOTHESIS - Ha1- Group A (Dashmool ghrita Nasya and Pathyadi Kwath)
is more effective than group B Pathyadi Kwathin the management of Ardhavavbhedaka (Migraine). Ha2- Group B Pathyadi Kwathis
more effective than group A (Dashmool ghrita Nasya and Pathyadi Kwath)
in the management of Ardhavavbhedaka (Migraine).
|