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CTRI Number  CTRI/2018/02/012163 [Registered on: 26/02/2018] Trial Registered Prospectively
Last Modified On: 29/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurveda medicated oil enema and janubasti(oil pulling on knee) in knee joint pain.  
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Efficacy of Janu Basti and Matra Basti with Shvadanstra Taila in the Management of Janu-Sandhigata Vata w.s.r. to Osteoarthritis of Knee Joint.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Bala Damor 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda  
Address  Department of Panchakarma National Institute of Ayurveda Madhav vilas palace ,near jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  9784627610  
Fax    
Email  jyotibaladamor1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopesh Mangal 
Designation  Assistant Professor  
Affiliation   
Address  Department of Panchakarma National Institute of Ayurveda Madhav vilas palace, jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Bala Damor 
Designation  PG Scholar 
Affiliation   
Address  Department of Panchakarma National Institute of Ayurveda Madhav vilas palace ,near jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  9784627610  
Fax    
Email  jyotibaladamor1992@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002  
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr jyoti bala damor  National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr jyoti bala damor  National Institute of Ayurveda  Dept. Of Panchkarma Madhav Vilas Palace Amer Road Jorawarsingh Gate Jaipur 302002
Jaipur
RAJASTHAN 		 9784627610

jyotibaladamor1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A matra basti  matra basti with shvandstra taila 70 ml for 14 days 
Comparator Agent  Group B janu basti   janu basti with shvandstra taila for 14 taila 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between 30 and 60 years of age
2.Patients with the clinical features of SandhigataVata (Osteoarthritis of Knee Joint.)
3.Patients fit for Basti and Janu Basti.
4.Patients with radiological findings of Osteoarthritis along with clinical features
 
 
ExclusionCriteria 
Details  1.Patients with severe form of systemic disorders
2.Pregnant women and lactating mother
3.Associated with simple or compound fractures
4.Patients unfit for Basti and Janu Basti.
5.Patients under gone knee replacement surgery.
6.Patients having chronicity more than 10 yrs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Subjective and objective parameter
 		 30 days
 
 
Secondary Outcome  
Outcome  TimePoints 
To find the comparative efficacy of the treatments indifferent groups.
 		 3 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2018 
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
Modification(s)  		 Not published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Ø Effect of Therapy on Sandhishoola (Knee Joint Pain): -

In Group A, the mean before treatment was 5.286 which improved to 3.714 after treatment. It showed an improvement with Mean Difference of 1.571 ±0.7559 (S.D) with 29.72%. The statistical analysis showed very significant result at p value (< 0.0005). 

In Group B, the mean score before treatment was 4.867 which improved to 2.733 after treatment. It showed an improvement with Mean Difference of 2.133±0.5164 (S.D.) with 43.82%.The statistical analysis showed extremely significant result at p value < 0.0001.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom of Sandhishoola, the two-tailed p value was 0.0327that was significant. it means that their statistical difference in the efficacy of both treatments on Sandhishoola.

Vitiation of Vata has an important role in the arising ofJanu-Sandhigata Vata. Shoola doesn’t occur without Vata. The Rukshata of Vata is cured by Tailadue to Snigdha. The Virya of Tailla is Ushna. It has effect on VatikaShoola. Tilataila has Snehana, Vedanasthapana, Sandhaniya, ShoolaPrashamana, Balyakarma. Basti is the best medicament for Vatika disorders. The properties of Basti which is VatanulomanaandSrotoshodhaka remove the impacted stool mass in the body and pacifying Vata inPakvashaya gives direct effect onJanu-Sandhigata Vata.Similarly, effect of Snehana and Swedana is worth mentioning, as Snehana is said to be Mardavakaraand Swedana is said to be Shoolaghna. Thus, irrespective of the material used these two procedures will have a certain positive effect towards reducing Shoola.

Ø Effect of Therapy on Sandhisotha (Swelling over joints): -

In Group A, the mean score before treatment was 1.833 which improved to 0.333 after treatment. It showed an improvement with Mean Difference of 1.500 ±0.674 (S.D). with 81.83% change. The statistical analysis showed very significant result at p value < 0.0005. 

In Group B, the mean before treatment was 1.750 which improved to 0.2500 after treatment. It showed an improvement with Mean Difference of 1.500±0.674 (S.D.). with 85.71% change. The statistical analysis showed significant result at p value < 0.0005. which 85.71% change.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom ofSandhisotha, the two-tailed p value was 0.7908that was insignificant. Its means there is no statistical difference in the efficacy of both treatments onSandhisotha.

The Ushnata applied by the Janu Basti procedure and UshnaVirya of drugs do the Pachana of the Dushya involved in the formation of Sotha. Due to this action the Sothamight have reduced in Group B.

Ø Effect of Therapy on Sandhigraha(Stiffness in joints): -

In Group A, the mean score before treatment was 2.000 which improved to 1.000 after treatment. It showed an improvement with Mean Difference of 1.000 ±0.6030 (S.D). with50% change. The statistical analysis showed very significant result at p value < 0.0020.

In Group B, the mean before treatment was 2.000 which improved to 0.6667 after treatment. It showed an improvement with Mean Difference of 1.333 ±0.4880 (S.D.). with 66.65% change. The statistical analysis showed extremely significant result at p value < 0.0001.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom ofSandhigraha, the two-tailed p value was 0.0459that was insignificant.

Joint stiffness is feature of JanuSandhigataVata which is caused by Rooksha and SheetaGuna of Vata.

The heat applied through the JanuBasti(retention of oil on knee joint)with ShvadanstraTaila, retention of Taila and UshnaVeerya of Taila along with its Snigdhata decreases the Rooksha and SheetaGuna and reduce the stiffness.  

JanuBasti being successful in relieving the stiffness because of itsSnehanaand Swedana effects simultaneously.Due to its SnehanaGuna, Vata gets pacified and Swedana causes relief inStabdhata, GauravaandSheeta due to its inherent qualities.

Ø Effect of Therapy on Sandhisphutana (Crepitus): -

In Group A, the mean before treatment was 1.929 which improved to 1.714 after treatment. It showed an improvement with Mean Difference of 0.214 ±0.4258 (S.D). with 50% change. The statistical analysis showed insignificant result at p value < 0.2500.

In Group B, the mean before treatment was 1.5333 which improved to 1.333 after treatment. It showed an improvement with Mean Difference of 0.2000 ±0.4140 (S.D.). with 13.346% change. The statistical analysis showed insignificant result at p value < 0.2500.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom ofSandhisphutana, the two-tailed p value was 0.2500that was insignificant. Its means there is no statistical difference in the efficacy of both treatments onSandhisphutana.

Effect of Therapy on Sparshasahyata (Tenderness): -

In Group A, the mean before treatment was 1.60 which improved to 0.2000 after treatment. It showed an improvement with Mean Difference of 1.400 ±0.547 (S.D). with 87.5% change. The statistical analysis showed insignificant result at p value < 0.0625.

In Group B, the mean before treatment was 1.66 which improved to 0.2000 after treatment. It showed an improvement with Mean Difference of 1.400 ±0.5477 (S.D.). with 87.5% change. The statistical analysis showed insignificant result at p value < 0.0625.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom ofSparshasahyata, the two-tailed p value was 0.2154 that was insignificant.Its means there is no statistical difference in the efficacy of both treatments onSparsaasahyata.

Tenderness is advanced stage of pain. Skin is the lodging place for Vata. Thus this can be said that tenderness is felt at different dermatomes when the nerve is compressed. MatraBastiwith ShvadanstraTailahas anti-inflammatory, analgesic properties, due to anti- inflammatory effects of Shvadanstra. It may help in reducing the compression of nerve by reducing inflammation of articular cartilages. Taila soothes the joints and also helps treating levels of synovial fluid making the entire structure lubricated and easy to rotate or to move. Taila improves blood supply to joints and restores integrity of vessels obliterated by spasm of internal damage. Thus reduction of Tenderness was seen in both the groups.

Ø  Effect of Therapy on WOMAC Index Score: -

In Group A, the mean before treatment was 55.21 which improved to 37.14 after treatment. It showed an improvement with Mean Difference of 18.071 ±8.453(S.D). with 32.729 % change. The statistical analysis showed insignificant result at p value < 0.0625.

In Group B, the mean before treatment was 50.467 which improved to 29.467 after treatment. It showed an improvement with Mean Difference of 21.000 ±4.781 (S.D.). with 41.611% change. The statistical analysis showed significant result at p value < 0.0001.

Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom of WOMAC Index Score, the two-tailed p value was 0.8955 that was insignificant.Its means there is no statistical difference in the efficacy of both treatments on WOMAC Index Score.

WOMAC index score includes pain, stiffness and physical function. Percentage of relief in Pain and stiffness was more in Group B than Group A, as discussed above. By improvement in pain and stiffness, the physical function also improves.

Ø Effect of Therapy on X-Ray: - No any significant radiological changes were found after treatment in both groups. May be due to the short course of treatment and follow-up, changes in X-Ray were not found.

Knee joint range of movements

·       Knee Joint Extension -In Group A, the mean before treatment was 11.667 which is same 11.667 after treatment. It showed an improvement with Mean Difference is zero. In group B SD is zero.

·       Knee Joint Flexion- In Group A, the mean before treatment was 104.62 which improved to 116.15 after treatment. It showed an improvement with Mean Difference of 11.538±5.911 (S.D.). with 9.93% change. The statistical analysis showed significant result at p value < 0.0001.

In Group B, the mean before treatment was 109.29 which improved to 119.29 aftertreatment. It showed an improvement with Mean Difference of -9.649±7.95 (S.D.). with9.643% change. The statistical analysis showed significant result at p value < 0.0006.

No any significant changes were found on extension of knee joint after treatment in both groups.Intergroup comparison was done to assess the comparative efficacy of both groups. When Group A was compared with Group B on symptom of range of movements (flexion)the two-tailed p value was 0.1829 & 0.2458 that was insignificant respectively right and left knee joint.These improvement in range of motion might be due to the improvement in other symptoms of the diseases such as pain, stiffness etc. Reduction in Pain, stiffness in turn might have overcome the restriction thus increasing the range of movements at knee joint. 


 
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