CTRI Number |
CTRI/2019/12/022344 [Registered on: 12/12/2019] Trial Registered Prospectively |
Last Modified On: |
05/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
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Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Additive effect of Dashmul Yog Basti along with Kumkum siddha Ghrita Nasya in Ardhavabhedak w.s.r. to Migraine |
Scientific Title of Study
|
“A randomized clinical comparative study to evaluate the effect of Dashmul Yog Basti followed by Kumkum Siddha Ghrita Nasya And Kumkum Siddha Ghrita Nasya in the management of Ardhavbhedak with special reference to Migraine.â€
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Trial Acronym |
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Secondary IDs if Any
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Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Amrut Salunke |
Designation |
H.O.D. & Asso. Professor |
Affiliation |
R.A.Podar Med(Ayu) College , Worli , Mumbai |
Address |
Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Mumbai MAHARASHTRA 400018 India |
Phone |
9819139017 |
Fax |
02224936881 |
Email |
dramrut16@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Dr Amrut Salunke |
Designation |
H.O.D. & Asso. Professor |
Affiliation |
R.A.Podar Med(Ayu) College , Worli , Mumbai |
Address |
Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai
MAHARASHTRA 400018 India |
Phone |
9819139017 |
Fax |
02224936881 |
Email |
dramrut16@gmail.com |
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Details of Contact Person Public Query
|
Name |
Dr Sonali Tadasarkar |
Designation |
Post Graduate Student |
Affiliation |
R.A.Podar Med(Ayu) College , Worli , Mumbai |
Address |
Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Mumbai MAHARASHTRA 400018 India |
Phone |
8600965073 |
Fax |
02224936881 |
Email |
sonali.t95@gmail.com |
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Source of Monetary or Material Support
|
H.O.D. , Shalakyatantra Dept. ,R A Podar Medical Ayurvedic College & M.A.Podar Ayu. Hospital , Dr. A.B.Road , Worli , Mumbai 18 |
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Primary Sponsor
|
Name |
HOD Shalakyatantra Dept R A Podar Medical Ayurvedic College |
Address |
H.O.D. , Shalakyatantra Dept. ,R A Podar Medical Ayurvedic College & M.A.Podar Ayu. Hospital , Dr. A.B.Road , Worli , Mumbai 18 |
Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
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No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Amrut Salunke |
R.A.Podar Med(Ayu) College & M.A.Podar Hospital |
O.P.D. of Shalakyatantra and Department of Shalakyatantra ,R.A.Podar Ayu(Med) College ,M.A.Podar HospitalDr. Annaie Besant Road ,Worli , Mumbai Mumbai MAHARASHTRA |
9819139017 02224936881 dramrut16@gmail.com |
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Details of Ethics Committee
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No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee R.A.Podar Medical (Ayu) College |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G43C||Periodic headache syndromes in child or adult, |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dashmul Yog Basti & Kumkum Ghrita Nasya |
1.] Dashmul Yog Basti :
-Niruha :
(Dashmula kwath Madhu Saindhava
Til Taila Dashmul kalka
Shatapushpa churna)
Quantity : 480 ml
-Anuvasan Basti :
Dashmula Taila 60 ml
2 cycles of Yog Basti each of 8 days
Route : Anal
2.]Kumkum Ghrita Nasya :
Kumkum Siddha Go-ghrita 6 drops in each nostril in morning for 7 days
(First cycle of Yog Basti will be followed by cycle of nasya which will be followed by 7 days gap again followed by basti & nasya)
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Comparator Agent |
Kumkum ghrita nasya |
Kumkum Ghrita Nasya :
Kumkum Siddha Go-ghrita 6 drops in each nostril in morning for 7 days
(First cycle of nasya will be followed by 7 days gap again followed by nasya) |
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Inclusion Criteria
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Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Individuals of either sex
2. Age- 18 years to 50 years
3. H/O- headache more than 6 months
4. Frequency of episodes- 3to5 episodes in one year
5. Patients having symptoms of Ardhavbhedak i.e Ardhashirovedana, Tod ,Bhed, shool, Prakash asahatva manya-bhru-akshi-karna vedana
6. Patient willing to take therapy and to give written consent.
7. Patient of controlled diabetes mellitus( fasting 70-110mg/dl Post prandial-110-140mg/dl)
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ExclusionCriteria |
Details |
1. Pregnant and lactating women
2. Patient suffering from major illnesses e.g Tuberculosis / Hypertension/ cardiovascular diseases/epilepsy/malignancy
3. Having H/O-head injury or trauma
4. HIV and HBSAg positive patients
5. Patient under psychiatric medication.
6. Patients having bleeding disorders.
7. Other types of headache.
8. Referred pain in one half of head due to diseases of eye ,nose,throat, ear.
9. Patient with complicated migraine, status migrainous, othalmic migraine, hemiplegic migraine etc.
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
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Open Label |
Primary Outcome
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Outcome |
TimePoints |
To evaluate the combined effect of Dashmul Yog Basti followed by Kumkum Siddha Ghrita Nasya in the management of Ardhavbhedak with special reference to Migraine. |
To evaluate the combined effect of Dashmul Yog Basti followed by Kumkum Siddha Ghrita Nasya in the management of Ardhavbhedak with special reference to Migraine by the end of 40 days |
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Secondary Outcome
|
Outcome |
TimePoints |
To compare the efficacy of Dashmul Yog Basti followed by Kumkum Siddha Ghrita Nasya and Kumkum Siddha Ghrita Nasya in the management of Ardhavbhedak with special reference to Migraine. . |
To compare the efficacy of Dashmul Yog Basti followed by Kumkum Siddha Ghrita Nasya and Kumkum Siddha Ghrita Nasya in the management of headache , aura & other symptoms seen in Ardhavbhedak by the end of 40 days. |
To evaluate the efficacy of Kumkum Siddha Ghrita Nasya in the management of
Ardhavbhedak with special reference to Migraine.
|
To evaluate the efficacy of Kumkum Siddha Ghrita Nasya in the management of headache & other symptoms seen in Ardhavbhedak by the end of 40 days.
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Target Sample Size
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Total Sample Size="60" Sample Size from India="60"
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)
|
15/12/2019 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Headache is commonest problem
experienced by humans
in day to day life. Migraine
is presented with symptoms like paroxysmal unilateral
headache with throbbing and pulsating type of pain. Some
patients may experience nausea (with or without vomiting), photophobia, phonophobia, with or without
aura.
According
to international headache society migraine is commonest neurovascular headache which constitutes 16% of primary
headache and affects
10%-20% of general population. WHO ranks migraine
among the world’s
most disabling medical
illness.During adolescence migraine becomes more common among
females and it will persist
for lifetime.
The word “MIGRAINE†is derived from Greek word “Hemi craniaâ€
which means “half of
head†because the
pain of migraine
often occurs on one side
of head. Sometime it spreads to entire
head. The term
migraine mainly refers
to a syndrome of vascular spasm of cranial blood vessels and it is usually
an episodic headache.
In
Ayurvedic Samhitas, migraine is found to be similar
to one of the Shirorogas named as Ardhavbhedak. Which is characterized by Ardhshir vedana means unilateral headache.
There are some other symptoms
of Ardhavbhedak can also correlate with migraine, such as
Toda, Bheda, Bhrama means pulsatind and
throbbing type of pain, vertigo.
Ardhavbhedak is one of the Shirorogas explained in classical ayurvedic texts.According to acharya Charaka,
vata dosha either
alone or along with Kapha seizes the
one half of head and causes Ativedana in sides of Manya(neck), Bhru(eyebrow), Shankha(temporal region),
Karna(ear), Akshi(eyes), lalatardh(one side
of forehead) and
if the symptoms
becomes aggravated it may
affects the function
of Netra and Shrotra.
The
proper history taking
of patient plays
important role in diagnosis of migraine. The line of treatment of modern science
includes acute rescue,
life style changes,
alternative remedies and prophylactic drugs.
The Triptans have improved acute treatment but overuse
of acute rescue
medication can causes
chronic daily headache.
Need of study
Modern medications gives instant
relief from pain
and other symptom
of migraine but underlying pathology goes on and progressively worsen the condition. There are some drawbacks of these medicines like
sedation, weight gain, drug dependency and recurrence. Therefore there is need of alternative therapy for migraine
pain management.
According to Ayurveda pain is present due
to Vata dushti.So there is need of such
therapy which can reduces the Vata dushti. Acharya
said that nasal route is the nearest route for treatment of Shirorogas
and Nasya Karma is
significant for all Urdhwajatrugat rogas. According to Kaiyadeva
Nighantu Kumkum has
Tridoshhar properties and also effective on shirorogas. Ayurveda considered Basti
is one of the best treatment for vatadushti
and it is main upakrama for vata.Acharya Charaka has given specific treatmen on Shirorogas
which includes Nasya and Basti. Drugs
included in Dashmul are specifically used in Vata dushtigat
rogas.
Hence I have
taken this subject for study:
“A randomized clinical comparative study
to evaluate the effect of Dashmul
Yog Basti followed by Kumkum
Siddha Ghrita Nasya
And Kumkum Siddha Ghrita
Nasya in the management of Ardhavbhedak with
special reference to Migraine,â€
|