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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | 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 | 2 | Intervention Arm | Procedure | - | 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. |