| CTRI Number |
CTRI/2025/02/080111 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of increasing dose of anuvasana vasti with dhanwantara taila and panchatiktaka ghrita in reducing pain ,stiffness and improving range of motion of knee joint. |
|
Scientific Title of Study
|
Effect of arohana anuvasana vasti with dhanwantaram taila and panchatiktaka ghrita in the management of osteoarthritis of knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhasina M Basheer |
| Designation |
PG Scholar Department of Panchakarma |
| Affiliation |
Government Ayurveda College Hospital Tripunitura |
| Address |
Deparment of Panchakarma ,Room number 135,Government Ayurveda College Hospital Tripunitura, Dhanwantari Nagar, Puthiyakavu P.O ,Ernakulam,Kerala.
Department of Panchakarma,Room number:135,Goverment Ayurveda College Hospital Tripunitura,Dhanawantari Nagar Puthiyakavu P O Ernakulam 682301
Ernakulam
KERALA
682301
India |
| Phone |
904883669 |
| Fax |
|
| Email |
muhasinambshr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simi Ravindran |
| Designation |
Associate Professor and HOD,Department of Panchakarma |
| Affiliation |
Panchakarama Hospital Poojappura |
| Address |
Department of Panchakarma,New Block,Government Ayurveda Panachakarma Hospital Poojappura,Poojapura P.O
Thiruvananthapuram
Department of Panchakarma, New Block,Goverment Ayurveda Panchakarma Hospital,Poojapura,Poojapura P.O Thiruvananthapuram 695012
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9496370179 |
| Fax |
|
| Email |
simisreehari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simi Ravindran |
| Designation |
Associate Professor and HOD,Department of Panchakarma |
| Affiliation |
Panchakarama Hospital Poojappura |
| Address |
Department of Panchakarma,New block,Government Ayurveda Panachakarma Hospital Poojappura,Poojapura P.O,
Thiruvananthapuram
Department of Panchakarma,New Block,Goverment Ayurveda Panchakarma Hospital Poojapura,Poojapura P.O Thiruvananthapuram 695012
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9496370179 |
| Fax |
|
| Email |
simisreehari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital Tripunitura,Dhanwantari nagar,Puthiyakavu P.O,Ernakulam,682301,Kerala,India |
|
|
Primary Sponsor
|
| Name |
Muhasina M Basheer |
| Address |
PG Scholar Department of Panchakarma,Government Ayurveda College Hospital,Puthiyakavu,Tripunitura |
| 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 |
| DrSimi Ravindran |
Government Ayurveda College Hospital ,Tripunitura |
Department of Panchakarma,Room No: 135,Government Ayurveda College Hospital Tripunitura,Puthiyakavu P.O ,682301,Ernakulam,Kerala Hospital,Puthiyakavu,Trippunitura,Ernakulam,682301,Kerala
Ernakulam
KERALA |
9496370179
muhasinambshr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee For Ethics in Research,Government Ayurveda College ,Tripunitura,Kochi,Kerala,682301 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: chakradutta 72/3-4, Procedure details: Procedure Reference: chakradutta 72/3-4, Procedure details: (Procedure Reference: chakradutta 72 /3-4, Procedure details: Participants will be instructed to come after taking light diet and after elimination of stool and urine.Participants will be advised to lie down on left lateral position on vasti table with left lower extrimity straight and rightlower extrimity flexed on knee and hip joint and advised to kept his left hand below the head.The sterilized syringe should be taken.The prescribed amount of sneha (taila and ghrita in the ratio 3:1 in escalating dose)which is taken in the measuring jar is transfered to the steel glass and will be made lukewarm by placing over hotwater bath.wearing sterile hand gloves ,hold the syringe in the left hand closing the tip with left index finger.Pour the oil into it and using the righthand place the handle and lock it.The syringe should be inverted and air should be evacuated by pressing the handle.little amount of oil will be applied over the nozzle and anus for lubrication.Per rectal examination will be done to rule out loaded rectum or any other obstructions.Holding the syringe in the right hand,gently insert the left index into the anus.Then the nozzle will be slowly introduced into the anus by sliding through the left index finger,after it is fully inserted the index finger is withdraw.Snehadravya pushed with uniform force not too slow not too fast.The total sneha will not be administered in order to avoid entrance of vayu into pakvashaya which may produce pain.After the administration,nozzle should be slowly and gently removed from the anal canal.Participants should be advised to lie supine ,mild massage over abdomen will be given.bend his legs at the knee and buttocks are hit by the heels.Participants are advised to lie down till he feels the urge.for all purpose warm water should be used .Till the sneha comes out participants will not be allowed to eat anything. )
(1) Medicine Name: panchatiktaka ghrita, Reference: bhaishajya ratnavali kushta adhyaya, Route: Rectal, Dosage Form: Ghrita, Dose: 36(ml), Frequency: od, Duration: 9 Days | | 2 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: chakradutta 72/3-4, Procedure details: (Procedure Reference: chakradutta 72 /3-4, Procedure details: Participants will be instructed to come after taking light diet and after elimination of stool and urine.Participants will be advised to lie down on left lateral position on vasti table with left lower extrimity straight and rightlower extrimity flexed on knee and hip joint and advised to kept his left hand below the head.The sterilized syringe should be taken.The prescribed amount of sneha (taila and ghrita in the ratio 3:1 in escalating dose)which is taken in the measuring jar is transfered to the steel glass and will be made lukewarm by placing over hotwater bath.wearing sterile hand gloves ,hold the syringe in the left hand closing the tip with left index finger.Pour the oil into it and using the righthand place the handle and lock it.The syringe should be inverted and air should be evacuated by pressing the handle.little amount of oil will be applied over the nozzle and anus for lubrication.Per rectal examination will be done to rule out loaded rectum or any other obstructions.Holding the syringe in the right hand,gently insert the left index into the anus.Then the nozzle will be slowly introduced into the anus by sliding through the left index finger,after it is fully inserted the index finger is withdraw.Snehadravya pushed with uniform force not too slow not too fast.The total sneha will not be administered in order to avoid entrance of vayu into pakvashaya which may produce pain.After the administration,nozzle should be slowly and gently removed from the anal canal.Participants should be advised to lie supine ,mild massage over abdomen will be given.bend his legs at the knee and buttocks are hit by the heels.Participants are advised to lie down till he feels the urge.for all purpose warm water should be used .Till the sneha comes out participants will not be allowed to eat anything. )
(1) Medicine Name: dhanwantaram tailam mezhukupakam, Reference: ashtanga hridaya sareerasthana garbhavyapath, Route: Rectal, Dosage Form: Taila, Dose: 108(ml), Frequency: od, Duration: 9 Days)
(1) Medicine Name: dhanwanataram taila mezhukupakam, Reference: ashtanga hridaya sareerasthana garbhavyapath , Route: Rectal, Dosage Form: Taila, Dose: 108(ml), Frequency: od, Duration: 9 Days |
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Participants among the age group 40-75 years who are willing to give written consent and are fit for anuvasana vasti |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled case of systemic illness
2.History of recent fracture in and around the knee joint
3.Presence of wound/ulcer in and around the knee joint.
4.Pregnant and lactating women |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain,stiffness and improving quality of life and assessed using WOMAC critera |
0th,10th and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain assessed by visual analogue scale
2.Range of movements of knee joint using goniometry
3.Samyak anuvasitha lakshana are assessed as per metioned in the samhita
4.Samyak snigdha lakshana are assessed by gradind |
1.pain assesssed by vas scale in 0th,10th and 28th day
2.range of movement of knee joint using goniometry in 0th ,10th and 28th day
3.samyak anuvasitha lakshana assessment in all days (9days)of procudure
4.Samyak snigdha lakshana are assessed in all days (9days)of procedure. |
|
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Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 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="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
|
This trial is conducted to assess the "Effect of Arohana Anuvasana vasti with Dhanwantara taila and Panchatiktaka ghrita in the management of Osteoarthritis of knee".The intervention will be given as rectal administaration of dhanwantaram taila and panchatiktaka ghrita in the ratio 3:1 for 9 days consecutively with a fixed escalating dose. Initially deepana pachana will be done for 3 days with gandharvahastadi kashyam and vaishavanara choornam.The study will be conducted in Government Ayurveda College Hospital Trippunitura.The study design is pre and post test design. A sample size of 27 will be selected based on the inclusion and exclusion criteria from the IPD of panchakarma department ,Goverment Ayurveda College Hospital Trippunitura .Data collection will be done using detailed case performa. The primary outcome pain ,stiffness and quality of life will be assessed with WOMAC criteria.The secondary outcome such as pain will be assessed with visual analogue scale ,range of motion with goniometry ,samyak anuvasitha lakshana as per samhitha ,samyak snigda lakshana using grading.During the treatment period patient will not be given any internal medications.The assessment will be taken on the 0th ,10th and 28th day of the procedure. Data collected will be analyzed through appropriate tests and conclusion will be drawn. |