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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   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.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
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  
 
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 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee R.A.Podar Medical (Ayu) College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G43C||Periodic headache syndromes in child or adult,  
 
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)  
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) 
 
Inclusion Criteria  
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)
 
 
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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
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 
 
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.

 
 
Target Sample Size   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

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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 crania” 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,”


 
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