FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083296 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two sudation therapy done with Horsegram-Blackgram fermented liquid and decoction in neck pain. 
Scientific Title of Study   Comparative Clinical Study to evaluate the efficacy of Ruksasweda with Kulathamasha Kanji and Kulathamasha Kashaya Nadi Sweda in Manyastambha 
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 Dinesh S 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9715477732  
Fax    
Email  drdineshdina.3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8217505755  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8217505755  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India 573201 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital 
Address  Thanniruhalla, Hassan 573201 
Type of Sponsor  Private 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 Dinesh S  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital  OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA 
9715477732

drdineshdina.3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital  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: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nADIsvedaH, नाडीस्वेदः (Procedure Reference: Charaka Sutrasthanam 14/29, Procedure details: Once the patient got his position, the generated steam in cooker is made to move on the neck region. There should be convenient distance in between the body part & nozzle. It prevents overheating as well as burn injury which could be occurred by droplet of water collected in nozzle. The steam should be continued move on neck region till getting the proper swedana lakshanas. If there is any lakshanas of Aswinna or Atiswinna, then patient should be treated accordingly.)
(1) Medicine Name: Kulatha Masha Kashaya, Reference: Charaka Samhita, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 0(NA), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-nADIsvedaH, नाडीस्वेदः (Procedure Reference: Charak Samhita Sutrasthanam 14/29, Procedure details: Once the patient got his position, the generated steam in cooker is made to move on the neck region. There should be convenient distance in between the body part and nozzle. It prevents overheating as well as burn injury which could be occurred by droplet of water collected in nozzle. The steam should be continued move on neck region till getting the proper swedana lakshanas. If there is any lakshanas of Aswinna or Atiswinna, then patient should be treated accordingly. )
(1) Medicine Name: Kulatha Masha Kanji, Reference: Sharangadhar Samhita, Route: Topical, Dosage Form: Not Applicable, Dose: 0(NA), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants having stiffness, pain and restricted range of movement of neck.
2. 20-60 years of either gender.
3. Participants who are willing to sign the informed consent.

 
 
ExclusionCriteria 
Details  1. Known cases of Hepatitis B, Herpes, psoriasis and cystic fibrosis.
2. Fractures of cervical vertebrae.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SUBJECTIVE PARAMETER:
1.Samyak Swedana lakshana
2.Ruk(pain)
3.Stamba (stiffness)
OBJECTIVE PARAMETER:
1. Spurling’s test
2. Range of Movement- Using Goniometer
 
7DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Improving lifestyle.  14days 
 
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 
Date of First Enrollment (India)   04/04/2025 
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="2"
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  
In today’s era it’s an alarming fact that the incidence of Manyastambha is increasing due to changes in occupational lifestyles, positional variations by depending upon several gadgets.A significant portion of the general population, ranging from 4.8%-79.5%, with a lifetime prevalence possibly reaching 86.8% has pain or stiffness on the neck.Especially the adult age group has a prime incidence.In oldage group it may be due to wear and tear of the cervical vertebrae.Modern medicine typically relies on NSAIDs, corticosteroids, and muscle relaxants for treatment, considering surgery for severe cases.
Ayurveda gives emphasis on Swedana, particularly In Manyastambha Ruksa Sweda, is highlighted while addressing Vata-Kaphaja Vikaras. Various forms of Swedana, including Nadi Sweda are utilized. In General practice Moolas and Patras are used in the form of Kashayakalpana.Many of these plants take years to mature into trees, Harvesting their roots directly could potentially lead to the extinction of these plants however the utilization of leaves in Nadi Sweda extends to other treatment as well. Moreover solely depending on one type of Kalpana might hinder our ability to fully understand the various effects that other Kalpanas can offer, Hence there is a need for easily accessible, practical, and effective alternatives. Masha and Kulatha exhibit inherent qualities of Swedana and conveniently feasible
In the context of Nadi sweda apart from Kasaya Kalpanas many other  Dravadravyas are mentioned for both Snigdha and Ruksa Sweda.Amla Kanji is one among that which possesses properties such as Ruksa, Teeksna, Suksma, Ushna,Vatakaphahara and it is Shothahara in nature making it may be suitable for Nadi Sweda therapy.
 
Close