CTRI

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CTRI Number

CTRI/2024/06/069605 [Registered on: 27/06/2024] Trial Registered Prospectively

Last Modified On:

15/06/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Effect of sudation therapy with Varunadi formulation in Lumbar Spondylosis

Scientific Title of Study

Effect of Varunadi Choorna Pinda Sweda in Lumbar 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 Fathima A
Designation	P G Scholar,Department of Panchakarma
Affiliation	Government Ayurveda Medical College and Hospital
Address	Government Ayurveda Medical College and Hospital,Pulimood Junction,Thiruvananthapuram KERALA India Thiruvananthapuram KERALA 695001 India
Phone	8848819910
Fax
Email	fathimayasar5@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Fathima A
Designation	P G Scholar,Department of Panchakarma
Affiliation	Government Ayurveda Medical College and Hospital
Address	Government Ayurveda Medical College and Hospital,Pulimood Junction,Thiruvananthapuram KERALA India Thiruvananthapuram KERALA 695001 India
Phone	8848819910
Fax
Email	fathimayasar5@gmail.com

Details of Contact Person
Public Query

Name	Dr Manju P S
Designation	Associate Professor,Department of Panchakarma
Affiliation	Government Ayurveda Medical College and Hospital
Address	Government Ayurveda Medical College and Hospital,Pulimood Junction,Thiruvananthapuram Kerala India Thiruvananthapuram KERALA 695001 India
Phone	9847317295
Fax
Email	manjumahesh1977@gmail.com

Source of Monetary or Material Support

Government Ayurveda Medical College and Hospital, Thiruvananthapuram Kerala 695001 India

Primary Sponsor

Name	Dr. Fathima A
Address	PG Scholar , Government Ayurveda Medical College And Hospital, Thiruvananthapuram
Type of Sponsor	Other [self]

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 Fathima A	Government Ayurveda Panchakarma Hospital,Poojappura,Thiruvananthapuram	In patient Department of Swasthvritta,Government Ayurveda Panchakrma Hospital,Poojappura,Thiruvananthapuram Thiruvananthapuram KERALA	8848819910 fathimayasar5@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITTEE (IEC) Government Ayurveda Medical College, Thiruvananthapuram	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: SANDHIGATAVATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	piNDasvedaH,Â à¤ªà¤¿à¤£à¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ	(Procedure Reference: Gada Nigraha, Procedure details: Intervention: Procedure Preparation of pottali Each drug will bought in raw form.Then it should be cleaned and dried properly.For preparing pottali, it should be pulverized to get fine powder.4 pottali were prepared each containing 250gms of varunadi choorna. The powder should be fried in the vessel till it attains a golden brown colour.it should be divided into 4 equalparts and tied into 4 pottalis. Poorvakarma Patient should be seated on the table/droni and Rasnadi choorna should be applied on the head. Pradhanakarma The hot pottali should be gently applied over the body, after confirming the temperature by applying pottalies on the dorsum of hand of therapist,(420 C - 450 C).Just pressing the body with pottali should be done, no need of kneading and massaging with the pottali. Both pottalis are used alternately after reheating tomaintain uniform temperature throughout the procedure. Same pottali can be used for three days. For whole body, it should be done for about 30 â€“ 45 minutes in the 7 positions. Samyak swinna lakshanas must be looked for. Paschathkarma After the procedure,thala should be removed with cotton and Rasnadi choorna should be applied over moordha. Patient should take complete rest for at least half an hour and should take bath in hot water. Study duration: Intervention- 7 days. Evaluation of the disease condition before treatment (0th day).)

Inclusion Criteria

Age From	30.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Participants with signs and symptoms of Lumbar Spondylosis along with x ray showing degeneration of lumbarspine 2. Participants aged between 30&60 years 3. Participants fit for rooksha sweda.

ExclusionCriteria

Details

1. Lumbar Spondylosis associated with any type of malignancy or neoplastic
infiltration.
2. Participants with uncontrolled hypertension, diabetes mellitus, major liver or renal
disorder.
3. Participants contraindicated for swedana in Ayurvedic classical textbooks

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Outcome measures are evaluated by comparing the pre and post measurements in VAS Scale, Range of movement by goniometer, and quality of life by Quebec low back pain	0th day,8th day

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="25"
Sample Size from India="25"
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)

20/07/2024

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 Applicable

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

Lumbar spondylosis is a condition caused by degeneration of the lumbar disc or facet joints..Degenerative changes cause the weakening of the disc fibers, causing wear and tear.Constant wear and tear cause inflammation and formation of mineral deposits within the discs. Due to similar presentations Lumbar spondylosis can be correlated with Kateegraha mentioned in our classics. Swedana is indicated in vathakaphaja rogas.As katee is vatha sthana and joints are kapha sthana, rooksha sweda can given to kateegraha.Symptoms such as thodha,aayama, sthamba ,graha etc are relieve suddenly by sweda. Varunadi choorna pinda sweda mentioned in the vathavyadhi chikitsa of Gadha Nigraham is indicated in vatha rogas. The gana used for varunadi sweda contains 8 drugs.All are having vatha hara and vathakapha hara properties.Varunadi gana contains 8 drugs such as Varuna,Eranda,Vathari,Mundi,Shigru, 2 Shathavari,Gokshura & Sarshapa.All of these drugs are shoolagna,shwayadugna and easily available. Study design is an experimental study with pre-post assessment without control group. Participant aged between 30-60 years registered in IPD of Government Ayurveda Panchakarma hospital, Poojappura, Thiruvananthapuram diagnosed to have Lumbar spondylosis and satisfying inclusion criteria will be selected. The base line data will be collected through interview,observation and questionnaire. After collecting base line data, detailed history and examination will be done using clinical case proforma. Choornapindasweda will be done up to 35 minutes for 7 days. Changes in low back ache, range of movements and functional assessment will be analysed before treatment and, after treatment on the 8th day . Depending upon the distribution of variables, it will be analysed according to statistical test.