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CTRI Number  CTRI/2025/11/096993 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to assess the effect of Mashabaladi Kwath Ghanavati and Kubja prasarani Tail in managing Cervical Spondylosis 
Scientific Title of Study   A Comparative Clinical study to evaluate the efficacy of Mashabaladi kwath Ghanavati with Kubja Prasarani tail in the management of Greeva Sandhigata Vata with reference 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 Subhendu Mohanty 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh 
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  6370404951  
Fax  0  
Email  mohantysubhendu230@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S D Khichariya 
Designation  Reader 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh 
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  9826196400  
Fax  0  
Email  drkhichariya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tribhuwan Singh Pawle 
Designation  Lecture 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh 
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  7000692791  
Fax  0  
Email  dr.tribhu1singh@gmail.com  
 
Source of Monetary or Material Support  
Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh India 492010 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chhattisgarh  
Address  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda College GE Road Raipur Chhattisgarh 492010  
Type of Sponsor  Other [Government Ayurved college Raipur Chhattisgarh 492010] 
 
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 Subhendu Mohanty  Dept of Kayachikitsa Shri Narayan prasad Awasthi Ayurved College & Hospital Raipur Chhattisgarh  OPD no 2&20 and male and female IPD Dept. of Kayachikitsa Shri NPA Govt Ayurveda College& Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
6370404951
0
mohantysubhendu230@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mashabaladi Kwath Ghanavati, Reference: Chakradata, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke Warm water), Additional Information: -
2Comparator ArmProcedure-grIvAbastiH, ग्रीवाबस्तिः (Procedure Reference: Chakradata, Procedure details: Preparation of Basti Banda in by black gram flour as dough ring is shaped as 2inches high and 4-5 inches diameter then filling the basti with medicated oil(Kubja Prasarani Tail) for 20to 30 minutes. GrIvAbastiH should be done in 3 sittings in 60 days ,10days of GrIvAbastiH 15 days interval. )
(1) Medicine Name: Kubja Prasarani Tail, Reference: Chakradata, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 60 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A.Patients having clinical symptoms of Greevasandhi gata vata (cervical spondylosis) i.e.
Neck pain, Neck stiffness, Neck swelling, Restricated movement of neck, numbness and
tingling sensation radiating arms with or without radiological changes.
B. Stenosis of spinal cord
C. Well diagnosed and confirmed patients of cervical spondylosis 
 
ExclusionCriteria 
Details  A. History of neck trauma and fracture.
B. Patients having a history of recent cervical, spinal or shoulder surgery or implanted
instrumentation or surgery for cervical spondylotic myelopathy.
C. Known case of Intervertebral disc prolapses.
D. Known case of Inflammatory arthritic conditions like Rheumatoid arthritis,
Ankylosing spondylitis & Malignancy, Tuberculosis, HIV Infection.
E. Conditions like uncontrolled hypertension and diabetes mellitus.
F. Pregnant and lactating mother.
G. Patients who are taken steroids and cytotoxic treatment.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the effect of Mashabaladi kwath Ghanavati with Greevabasti of kubja prasarani tail in the management of Greeva sandhi gata vata(Cervical spondylosis)  60 days (15 days follow up and 15 days post trial follow up) 
 
Secondary Outcome  
Outcome  TimePoints 
To study efficacy & adverse effect of Mashabaladi kwath Ghanavati with Greevabasti of kubja prasarani tail in the management of Greeva sandhi gata vata(Cervical spondylosis)  60 days( 15 days for follow up and 15 days for post trials follow up) 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/03/2026 
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="1"
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  

 Greeva sandhi gata vata is a degenerative type of pathological conditions in the body can be considered under the broad umbrella “Vata vyadhi”. Sandhi gata vata is mentioned under Vata vyadhi. Greeva sandhi gata Vata is a Vata-dominant condition that affects the cervical region (neck area). Though it is not directly mentioned in the Brihatrayi, Ayurvedic references allow us to treat it as an individual Pathology. When aggravated Vata Dosha accumulates in the Greeva Asthi Sandhi (cervical joint) which leads to Greeva sandhi gata vata, leading to symptoms of sandhi gata Vata. In Vata Vyadhi chikitsa , Acharya Charak mentions sandhi gata Vata. The symptoms of sandhi gata Vata, as outlined in Ayurvedic classics, includes    Shoola (pain),   Prasarna Achunchan Savedana (pain full flexion and extension), Shotha (swelling),Vatapurnadritisparsha (sensation of fullness and heaviness) ,Hanti Sandhi gatah (impairment or difficulty in joint function).Cervical spondylosis is the most prevalent degenerative condition of the cervical spine, predominantly affects individuals aged 40 and older. Progressive degenerative changes, including intervertebral disc desiccation, degeneration of uncovertebral and facet joints. Osteophyte formation frequently accompanies these changes, potentially causing axial neck pain, neck stiffness, Restricated movement of neck significantly impairing daily function and quality of life. Given its prevalence and associated disability, cervical spondylosis imposes a substantial economic burden, necessitating timely recognition and evidence-based management to mitigate this condition’s impact on patient`s lives.

The prevalence of cervical spondylosis was 13.76%, although it differed significantly among the urban, suburban, and rural populations (13.07%, 15.97%, and 12.25%, respectively). Moreover, it was higher in females than in males (16.51% vs 10.49%). The highest prevalence was in the age group from 45 to 60 years old. There were positive associations between engaging in mental stress, prolonged computer use, overexertion and repeated spinal strain from travels or sports, high housework intensity and sleep duration of less than 7 h/day with cervical spondylosis.

NEED OF STUDY: -1.The prevalence of cervical Spondylosis in India varies with studies reporting figures ranging from 13.76-28.6%, mainly 13.76% with Variation across urban, suburban and rural populations.

2.Greeva Sandhigata vata is the most common degenerative disorder that affects the movements of the upper limbs particularly in most productive period of time.

3. Even though a lot of medications were invented in these contemporary medical sciences that there are no satisfactory treatments for degenerative joint disorders.

4.By taking into consideration, the prevalence rate of cervical spondylosis and overcoming the above expensive therapeutics, there is a great need to find out effective management of Greeva sandhi gata vata in ayurvedic.

5.The ayurvedic medicines available for Greeva Sandi gata vata was statistically significant improvement in some parameters in Greeva sandhi gata vata. But they are does not have much more effect on the specific symptoms as Neck pain, Neck stiffness, Restricated movement of neck, Pnumbness, Headache.

6. So, going to use Masha Baladi kwatha Ghanavati described by Acharya Chakradatta and Kubja Prasarani tail also described by Acharya Chakradatta in the form Greeva Basti. They can be producing beneficial and positive effects in Greeva sandhi gata vata That’s why selected this topic and presented it.

BASIS OF DRUG SELECTION -In Ayurveda for the management of Greeva sandhi gata vata; the concept of samprapti Vighatana is useful and is done by the use of Deepan and Pachan medicines which will be beneficial to reduce the formation of Aama dosha. Analysis of samprapti Vighatana Chikitsa of Greevasandhi Vata (Cervical Spondylosis) by Mashabaladi Kwatha Ghatavati ingredients such as eranda , bala, Masha and Kapikacchu will work together to pacify Vata and kapha doshas with properties, like Ushna Virya (hot potency) and Guru Snigdha (heavy and unctuous properties), and Eranda, Masha, Rasna & Hingu having anti-inflammatory, antioxidant and analgesic properties. Bala having nourishing and strengthening properties (Balya). Kapikacchu and Ashwagandha has rejuvenating and nervine-tonic properties and Rasayana .Kubja prasarani taila has ingredients like Prasarani, Pippali, Shatpushpa, Chitraka, Devadaru, Rasna, Jatamansi, Bala, and Saindhava Lavana, which will work together to pacify Vata dosha with properties like Katu, Tikta Rasa and Ushn virya (hot potency), and will contribute to their therapeutic effect as specific vatahar. Prasarani, Pippali, Devadaru, Rasna & Chitraka as vata pacification, pain relief (Shoolahara), inflammation reduction (Shothahara), analgesic, antioxidant, and digestive (eepana Pachana). The Rasayana properties of the ingredients promote overall rejuvenation and well-being.

This is randomized doubled armed open level clinical study. A  total 40 patients will be enrolled and located  into two groups on the basis of assessment criteria (subjective criteria) of Greeva sandhi gata vata (Cervical Spondylosis)with 15 patients each.  In Group -A 20 patients will take 500mg of Mashabaladi kwath Ghanavati twice in a day with Luke warm water& Group-B  20 patients will take 500mg of Mashabaladi kwatha Ghanavati twice in a day with Luke warm water with Greeva basti of kubaj prasarani tail. To Compare the efficacy of Mashabaladi kwath Ghanavati with Greeva Basti of kubja prasarani tail in management Greeva sandhi gata vata disease (cervical spondylosis).To Compare the efficacy of Mashabaladi kwath Ghanavati with Greeva Basti of kubja prasarani tail in management Greeva sandhi gata vata disease (cervical spondylosis).To study aims to evaluate and compare the  clinical efficacy of Mashabaladi Kwath Ghanavati with Greeva basti of Kubja prasarani Tail in the management of Greeva sandhi gata vata ( cervical spondylosis)

                                    
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