| CTRI Number |
CTRI/2025/02/080898 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [External Panchakarma Procedure] |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study Between Two External Panchakarma Procedures,Nirgundi Patra Pinda Sweda And Dashamuladi Upanaha Sweda In Knee Joint Pain. |
|
Scientific Title of Study
|
A Comparative Study Of Nirgundi Patra Pinda Sweda And Dashamuladi Upanaha Sweda In Sandhigat Vaat. |
| 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 Rishikesh Ananda Deshmukh |
| Designation |
M.D. Scholar Panchakarma Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Department of Panchakarma Shree Saptashrungi Ayurved
Mahavidyalaya and Hospital,Kamal nagar,Hirawadi, Panchavati, Nashik,
Maharashtra.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9869362632 |
| Fax |
|
| Email |
deshmukh.rishi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Shivaji Phadol |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Department of Panchakarma Shree Saptashrungi Ayurved
Mahavidyalaya and Hospital,Kamal nagar ,Hirawadi, Panchavati, Nashik,
Maharashtra.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975641619 |
| Fax |
|
| Email |
ravindrasphadol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Shivaji Phadol |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Department of Panchakarma Shree Saptashrungi Ayurved
Mahavidyalaya and Hospital,Kamal nagar ,Hirawadi, Panchavati, Nashik,
Maharashtra.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975641619 |
| Fax |
|
| Email |
ravindrasphadol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi, Panchavati,Nashik, Maharashtra,India, Pin code- 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi, Panchavati, Nashik, Maharashtra, India, Pin Code-422003 |
| Type of Sponsor |
Other [Private Ayurved 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 Rishikesh Ananda Deshmukh |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
Panchakrama OPD,Ground floor,Deparment of Panchakarma,Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi, Panchavati, Nashik.
Nashik
MAHARASHTRA |
9869362632
deshmukh.rishi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Charak sutrasthan 14/41, Ashtanghriday sutrasthan 17/06, Procedure details: Procedure details: PURVAKARMA 1)Aatursiddhata-Patients will be selected as per inclusive criteria & will be duly prepared. 2)Aushadhasiddhata-Group A: Nirgundi patra pinda • Fresh Nirgundi leaves (500 gm) • Saindhav lavana (10 gm) • Nirgundi churna (20 gm) • Murchita Tila tail (20 ml) 3)Upakaran Siddhata-Abhyanga Table, Vessels having round bottom, Spoon, Handle, Plate, Gas cylinder, Stove, Knife, Napkin Cotton cloth – 2 (approx. 18 inches square cloth) Threads – 2 (5 feet long cotton threads) PRADHANKARMA Name of procedure-By giving prone/sitting position to patient, prepared pottali will be administered in circular manner on affected Janusandhi in prescribed time. Position of Patient-Proneposition/sitting. Administration of Pottali-Tapping,Pressing, Squeezing PASCHAT KARMA -Sponging Duration- 15 to 20 min approx. daily for 7 days.))
| | 2 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Ashtanghriday sutrasthan 17/1, Sushrut Chikitsa 32/3, Sushrut Chikitsa 32/12, Procedure details: PURVAKARMA
Aatursiddhata- Patients will be selected as per inclusive criteria & will be duly prepared.
Aushadhasiddhata-Group B: Dashmuladi
Upanaha
• Dashmul Churna
(100 gm)
• Saindhav lavana
(30 gm)
• Amla Dravya-
Kanji (50 ml)
• Murchita Til tail
(20 ml)
UpakaranSiddhata-Abhyan Table, Vessels having round bottom,Spoon, Handle, Plate, Gas cylinder, Stove,Napkin, Bowl Manjarpat cloth / Cotton
cloth.
PRADHANKARMA
Name of Procedure-By giving prone/sitting position to patient, prepared Upanah will be administered in circular manner on affected Janusandhi in prescribed time.
Position of Patient- Prone position/sitting
PASCHAT KARMA
Sponging
Duration- After 6 hr approx. daily for 7 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient presenting the symptoms of Sandhigat vaat at Janusandhi like
Shoola, Shotha, Sparshasahatva, Kriyakashtata (Prasaran
Aakunchanayoho vedana), Sthambha.
2) Patients indicated for Patra pinda sweda and Upanaha sweda karma.
3) Age : 30 to 60 years
4) Gender : Male and Female Both |
|
| ExclusionCriteria |
| Details |
1) Patient having congenital Structural Deformities.
2) Patient having fracture and needs surgical care will be excluded.
3) Sandigat vaat at Janusandhi associated with Paralysis, RA, Post
operative cases(within 2 month after surgery), Neurological disorder
etc.
4) Patient unfit for swedana.
5) Age below 30 years and above 60 years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the sign and symptoms of Sandhigat Vaat |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of Sandhigata Vaat |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/03/2025 |
| 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="1"
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
|
Objectives :- A) Aim / Primary Objective
To compare the effect of Nigrundipatra pinda sweda and Dashmuladi Upanaha sweda in Sandhigat vaat at Janusandhi.
B) Secondary Objective 1) To study the Sandhigat Vaat according to Ayurveda and Modern science. 2) To study concept of Swedana karma through Ayurvedic literature. 3) To study literature review of Nirgundi patra pinda sweda and Dashmuladi upanaha sweda in Sandhigat vaat. 4) To study the efficacy of Nirgundi patra pinda sweda and Dashmuladi upanaha sweda in Sandhigat vaat at Janu sandhi.
PARTICIPANTS
80 Adults diagnosed with Sandhigat Vaat , meeting inclusion and exclusion criteria from OPD and IPD of department of Panchakarma, Shree Saptashrungi Mahavidyalaya and Hospital Nashik
Interventions
Group A – Nirgundi patra pinda sweda for 7 days Group B – Dashmuladi upanaha sweda for 7 days Follow up – On 7th & 14th day
Primary Outcome : Reduce the sign and symptoms of Sandhigat Vaat
Secondary Outcome: No recurrency of Sandhigat Vaat
Treatment Duration : 7 Days ASSEMENT :0th , 7th , 14th Days
Data Analysis : Data will be analysed using appropriate statistical methods. |