| CTRI Number |
CTRI/2026/02/103096 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Kottamchukadi Churna Pinda Sweda in Patients with Cervical Spondylosis. |
|
Scientific Title of Study
|
A Single Arm Clinical Trial To Study The Effect Of Kottamchukadi Churna Pinda Sweda In Manyastambha With Special 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 |
Savyasachi Sanjay Badodkar |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchakarma, SMBT Ayurved College and Hospital, Nanadi Hills, Dhamangaon, Ghoti, Igatpuri, Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7218548135 |
| Fax |
|
| Email |
savyasachibadodkar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Ramrao Kurawar |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchakarma, SMBT Ayurved College and Hospital, Nanadi Hills, Dhamangaon, Ghoti, Igatpuri, Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
8793655354 |
| Fax |
|
| Email |
drrashmikurawar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savyasachi Sanjay Badodkar |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Panchakarma, SMBT Ayurved College and Hospital, Nanadi Hills, Dhamangaon, Ghoti, Igatpuri, Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7218548135 |
| Fax |
|
| Email |
savyasachibadodkar20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Savyasachi Sanjay Badodkar |
| Address |
Department of Panchakarma, SMBT Ayurved College and Hospital, Nanadi Hills, Dhamangaon, Ghoti, Igatpuri, Nashik 422403, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Savyasachi Sanjay Badodkar |
SMBT Ayurved College and Hospital |
OPD NO.19 Department of Panchakarma, SMBT Ayurved College and Hospital,Dhamangaon
Nashik
MAHARASHTRA |
7218548135
savyasachibadodkar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT AYURVED COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M629||Disorder of muscle, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Charak Samhita Sutra Sthana 14/41, Procedure details: Procedure of Kottamchukadi Churna Pinda Sweda
1) Materials Required :-
Kottamchukadi Churna – 500 g
Cotton cloth (18-inch square) – 1
Cotton thread (5 feet) – 1
Round-bottom vessel
Gas stove
Big spoon
2) Purvakarma :-
Select indicated and fit patient.
Perform general, systemic examination, Ashtavidha and Dashavidha Pariksha; record vital signs.
Take written consent.
Ask patient to empty bowel and bladder.
3) Preparation of Bolus :-
Heat 500 g Kottamchukadi Churna slowly in a vessel with continuous stirring until it turns slightly reddish.
Spread churna on cotton cloth, make a round bolus, and tie with thread.
Bolus should be firm, neither too tight nor loose.
4) Pradhanakarma :-
Test temperature of bolus on dorsum of hand.
Apply gently over Manya (neck) region.
Reheat bolus when it cools and reapply.
Continue for 20 minutes or till proper sweating occurs.
5) Paschatkarma :-
Record vital signs.
Allow patient to rest for a few minutes.
Wash treated area with warm water.
Advise suitable diet and regimen.
6) Caution :-
Procedure should be continued till Samyak Swinna Lakshanas (proper sweating and lightness) appear.)
(1) Medicine Name: Kottamchukadi Churna, Reference: Sahastra Yoga Tail Prakarnam, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical signs and symptoms of Manyastambha like stiffness and pain in the neck region.
2.Patients fulfilling the subjective and objective criteria
3.Patient who will give consent for procedure.
4.Age group between 40 to 70 irrespective to gender socio economic status occupation
marital status |
|
| ExclusionCriteria |
| Details |
1.Patients with history of fracture or dislocated of cervical region.
2.Patients with traumatic infective neoplastic spine.
3.Tuberculosis of spine.
4.Patients having automotive deformities like ankylosing spondylitis spinal cord abscess Rheumatoid arthritis as well as congenital structural disorder will be excluded.
5.Traumatic disorders like cervical strain injuries to intervertebral joints ligaments and muscles compression factors vertebral process fracture and ruptured disc. Patients with other joints disorder which are not relates to Manyastambha will be exclude |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in sign and symptoms of Manyastambha like pain and stiffness.
2. Assessed By VAS Scale and Stiffness Score. |
1. Total Duration of Treatment- 7 Day
2. Follow up on - Day14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
02/03/2026 |
| 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="6"
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
|
Title :- A SINGLE ARM CLINICAL TRIAL TO STUDY THE EFFECT OF KOTTAMCHUKADI CHURNA PINDA SWEDA IN MANYASTAMBHA WITH SPECIAL REFERENCE TO CERVICAL SPONDYLOSIS.
INTRODUCTION :- Manyastambha mainly affects the neck. In this condition, the back of the neck becomes stiff and rigid, and it’s hard to move the neck. The main symptoms are pain and stiffness in the neck(3) . In today’s modern lifestyle, many factors like sitting for long hours at a computer, riding two-wheelers frequently, lack of neck exercises, wrong sitting posture, and mental stress increase Vata, and when Kapha blocks the movement of Vata, it leads to stiffness in the neck muscles. This causes Manyastambha. A special type of swedana called Churna Pinda Sweda is a type of Ruksha Swedana (dry fomentation) therapy used in Ayurveda. It involves applying heat to the body using a warm bolus (pouch) made of medicated powders (churna). This therapy is especially useful in Vata-Kapha disorders like Manyastambha, where there is stiffness, heaviness, and pain in the neck. As per treatment of analgesic and physiotherapy gives temporary relief but not the cure of disease. Here’s Ayurveda plays important role in the management of Manyastambha with the help of Churnapinda swedan. It is easy for administration and helps in relieving pain and stiffness in Manyastambha.
Null Hypothesis (H0) :- “Kottamchukadi churna pinda sweda is not effective in manyastambha with special reference to cervical spondylosis”
Alternative Hypothesis (H1) :- “Kottamchukkadi Churna Pinda Sweda is effective in Manyastambha with special reference to Cervical Spondylosis.”
|