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CTRI Number  CTRI/2024/07/071570 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A comparative clinical study to assess the role of raktamokshana (modified shringa yantra) with panchatikta ghrita guggulu and agnikarma with panchatikta ghrita guggulu in the management of manyagata vata w.s.r. to cervical spondylosis.  
Scientific Title of Study   A comparative clinical study to assess the role of raktamokshana (modified shringa yantra) with panchatikta ghrita guggulu and agnikarma with panchatikta ghrita guggulu in the management of manyagata vata w.s.r. to cervical spondylosis.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Chahal  
Designation  PG Scholar (Shalya) 
Affiliation  D. Y. Patil School of Ayurveda Nerul Navi Mumbai  
Address  D. Y. Patil school of Ayurveda deemed to be university nerul navi mumbai.
D. Y. Patil school of Ayurveda deemed to be university nerul navi mumbai. sec 6
Thane
MAHARASHTRA
400706
India 
Phone  8168403696  
Fax    
Email  www.kirtichahal04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kirti Chahal  
Designation  PG Scholar (Shalya) 
Affiliation  D. Y. Patil School of Ayurveda Nerul Navi Mumbai  
Address  D. Y. Patil school of Ayurveda deemed to be university nerul navi mumbai.
D. Y. Patil school of Ayurveda deemed to be university nerul navi mumbai. sec 6
Thane
MAHARASHTRA
400706
India 
Phone  8168403696  
Fax    
Email  www.kirtichahal04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mayur Pawaskar  
Designation  Associate Professor 
Affiliation  D. Y. Patil School of Ayurveda, Nerul, Navi Mumbai  
Address  D. Y. Patil school of Ayurveda deemed to be university nerul navi mumbai.
D. Y. Patil deemed to be university school of Ayurveda nerul navi mumbai. sec 6
Thane
MAHARASHTRA
400706
India 
Phone  9004215670  
Fax    
Email  mail@drmayur.com  
 
Source of Monetary or Material Support  
OPD no 3 D Y Patil School of Ayurveda Nerul Navi Mumbai 
 
Primary Sponsor  
Name  Dr Kirti chahal 
Address  D. Y. Patil school of Ayurveda Nerul, Navi mumbai Deemed to be university PIN code 400706 
Type of Sponsor  Other [no any] 
 
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 Mayur Pawaskar  D Y Patil Ayurvedic hospital   D Y Patil School of Ayurveda Deemed to be university Nerul Navi Mumbai Maharashtra
Thane
MAHARASHTRA 		 9004215670

mail@drmayur.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: MANYASTAMBAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma (viShopakramaH), अग्निकर्म (विषोपक्रमः) (Procedure Reference: Sushrut Samhita 11/10, Procedure details: agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita sutra sthana 11/10, Procedure details: POORVA KARMA: • Patient’s consent to undergo Agnikarma treatment. • Inj. T.T 0.5ml Intra Muscular will be given half an hour before procedure. • Most tender sites will be marked with a surgical skin marker on the neck with proper space between each point • Preparation of the local part: The selected site will be cleaned with ‘Triphala Kwatha’ or ‘Normal saline’. • Patient will be explained about procedure in details PRADHAN KARMA Position of the Patient:- Prone Swarna Shalaka will be held with an artery forceps. One end of Shalaka will be placed on the site of neck & the other end will be burnt with a candle/spirit lamp. After intolerable heat sensation complained by the patient, the shalaka will be removed and placed on the other sites. All the marked and most tender sites of the neck will be treated and ½ Angul (approx.1cm) space will be kept between two Samyak Dagdhas. PASHCHAT KARMA • Yashtimadhu ghrita, will be applied prior to dressing. It will help to reduce the burning sensation and pain caused by the heat burns along with facilitation of faster healing. • Patient will be advised to take rest and avoid water contact on operated site for 24 hours. ))
(1) Medicine Name: Panchatikta Ghrita Guggulu, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 1 Months
2Intervention ArmProcedure-SrRu~ggAvacaraNam, श्रृंगावचरणम् (Procedure Reference: Sushruta samhita sutra sthana 13/6 , Procedure details: POORVA KARMA • Patient’s consent to undergo Raktamokshana treatment. • Inj. T.T 0.5ml Intra Muscular will be given half an hour before procedure. • Most tender sites will be marked with a surgical skin marker on the neck with proper space between each point. • Patient will be explained about procedure in details. PRADHANA KARMA Position of the Patient:- Prone Local site will be cleaned with antiseptic solution. Sterile fiber cups (modified Shringa Yantra) will be placed on the marked sites. After proper vasodilatation, multiple pricks will be made on the marked sites with a sterile needle no. 26 and fiber cups will be applied The cups will be removed after complete cessation of blood flow/oozing of blood. PASHCHAT KARMA Haridra Churna will be applied at the Raktamokshana site. Patient will be advised to take rest and avoid water contact on operated site for 24 hours. )
(1) Medicine Name: Panchatikta ghrit guggulu , Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with symptoms of Manyagata Vata w.s.r. to cervical spondylosis
Gender-Both male and female
Age-30-60 years
X-Ray showing early degenerative changes

 
 
ExclusionCriteria 
Details  Trauma
Potts spine
Ankylosing spondylitis
Kyphosis
Rheumatoid arthritis
Traumatic inter vertebral disc prolapsed
Peripheral neuropathies 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
➢ To evaluate the role of Agnikarma in the management of Manyagata Vata.
To evaluate the role of Raktamokshana in the management of Manyagata Vata.
➢ To evaluate the role of Raktamokshana in the management of Manyagata Vata.

➢ To compare the role of Agnikarma and Raktamokshana in the management of Manyagata Vata i.e., neck pain, stiffness in the vertebral joint, pain radiating to upper extremities etc. 		 60 Days


➢ To evaluate the role of Raktamokshana in the management of Manyagata Vata.

➢ To compare the role of Agnikarma and Raktamokshana in the management of Manyagata Vata i.e., neck pain, stiffness in the vertebral joint, pain radiating to upper extremities etc. 
 
Secondary Outcome  
Outcome  TimePoints 
➢ To compare the role of Agnikarma & Raktamokshana in the management of Manyagata Vata i.e., neck pain, stiffness in the vertebral joint, pain radiating to upper extremities etc.  60 Daya 
 
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   Phase 3 
Date of First Enrollment (India)   09/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Neck pain or Cervical pain, stiffness of neck region, radiating pain in shoulder region or upper extremities is a common clinical presentation of musculoskeletal disorders, which is highly common these days to almost two-thirds of the population and is more common in women than men1.

According to Ayurveda texts, wrong sleeping positions, use of large pillow, sleeping during day, wrong postures i.e., watching upwards, downwards for long time, due to stressful lifestyle and various unhealthy food habits Vata in our body gets vitiated2. This further gets localized in the Manyapradesh, after which the vitiated Vata diminishes Shleshakkapha at vertebral level causing further Vataprakop. Thereafter, vitiated Vata involves Mamsa and Asthidhatu of cervical region and causes symptoms like neck pain, restricted movement of neck etc. which is named as Manyagata Vata. The exact description of Manyagata Vata is not found as a separate disease but, mentioned as one of the Vatavyadhi in Susruta Nidansthan3. Further, based on clinical features, Manyagata Vata can be co-related with cervical spondylosis.

 
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