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CTRI Number  CTRI/2020/09/027735 [Registered on: 10/09/2020] Trial Registered Prospectively
Last Modified On: 02/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma procedure]  
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to evaluate the effect of Panchakarma(basti) in treating knee joint pain.  
Scientific Title of Study   Evaluation of kala basti protocol with Patoladi-ksheera niruha basti and ksheerabala thaila anuvasana basti in Osteoporosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay Bhaskar S 
Designation  PG Scholar 
Affiliation  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya  
Address  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9496433346  
Fax    
Email  dr.vijaybhaskars1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep L Grampurohit 
Designation  Professor 
Affiliation  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya  
Address  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep L Grampurohit 
Designation  Professor 
Affiliation  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya  
Address  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964144197  
Fax    
Email  pradeepgrampurohit@gmail.com  
 
Source of Monetary or Material Support  
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya  
KLE AYURVEDA PHARMACY,Khasbag,Belagavi 
 
Primary Sponsor  
Name  KLE University 
Address  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya ,Shahapur, Belagavi 590010 
Type of Sponsor  Research institution and hospital 
 
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 Vijay Bhaskar S  KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya   OPD NO:4,Panchakarma department
Belgaum
KARNATAKA 		 9496433346

dr.vijaybhaskars1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital, Shahapur, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Patoladi-ksheera niruha basti and Ksheerabala thaila anuvasana basti.  Every day local abhyanga will be done with murchita tila taila followed by nadi sweda,later to this subject will be posted for patoladi ksheera basti and anuvasana basti with ksheera bala on alternate days following the kala basti shedule. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 35-65 years of either sex.
2.Patients of Osteoporosis diagnosed by B.M.D test (t-score-2.5 and below).
3.Patients complaining of classical symptoms of Asthikshaya like joint pain, pain in the bones etc.
4.Patient fit for Basti Karma.
 
 
ExclusionCriteria 
Details  1.Patients with endocrine disorders (Hyperthyroidism,hyperparathyroidism, Untreated Cushing syndrome)
2.Patients suffering from pathological Osteoporosis and neoplasms of the bone.
3.Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
4.Patients suffering from Mal-absorption syndrome.
5.Patients undergone Organ transplantation or on immunosuppressive therapy.
6.Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout , SLE, Psoriatic arthritis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)REDUCTION IN PAIN- Assessed using Visual analogue scale and using grading for tenderness
2)REDUCED GENERAL DEBILITY- assessed using grading for general debility
3)Changes in serum calcium and alkaline phosphatase 		 16th and 48th day 
 
Secondary Outcome  
Outcome  TimePoints 
improved quality of life in patients with osteoporosis assessed by Medical Outcomes Survey 36-item short form questionnaire (SF-36)  48th day 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/12/2020 
Date of Study Completion (India) 15/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The outcome of the study will be communicated to peer reviewed journals for wider dissemination. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary                                        WHO defines Osteoporosis as “a progressive systemic disease, characterized by low bone density and micro-architectural deterioration in bone that predisposes patients to increased bone fragility and fractures”.According to recent statistics from the International Osteoporosis Foundation, worldwide, 1 in 3 women over the age of 50 years and 1 in 5 men will experience osteoporotic fractures in their lifetime. Every fracture is a sign of another impending one. Moreover, osteoporosis results in a decreased quality of life, increased disability-adjusted life span, and big financial burden to health insurance systems of countries that are responsible for the care of such patients. With an early diagnosis of this disease before fractures occur and by assessing the bone mineral density and with early treatment, osteoporosis can be prevented. It is also important to recognize that the ideal drugs for the treatment of osteoporosis or other bone disorders have yet to be developed. Drugs or therapies which are inexpensive, yet effective with minimal side effects are need of the hour. They must encompass effectiveness to prevent fractures and disease deformities in the enormous number of individuals who will are and will be at risk of bone disease as the population ages. 

                                     Asthi is considered as one among the sapta dhatus and the whole body is dependent on asthi for dharana or stability. Kala is defined as ‘Dhatvashayantara Maryada’ i.e. membranous structure which separates or limits Dhatus and Ashayas. Treatment which is having an effect on kala helps to maintain the normal functioning of the dhatu which is related to it. Pureesha dhara kala/pakwasaya is same as that of asthi dhara kala. Pakwashaya is the vishesha sthana of vata. Vata and asthi are having asraya asryi bhava in a reciprocal way, increase in vata leads to asthi kshaya. Basthi which is considered as ardhachikitsa, act on pakwashaya, thus for diseases of asthi dhatu caused by vata dosha, basti is said to be the primary choice of treatment. Treatment of Asthigata Vikaras is explained as; Basti with Ksheera and Ghritha processed with Tikta Dravyas .Patoladi ksheera basti is having tikta dravyas like patola ,arishta , ushira , chaturangula, hribera, rohini, tikta, madana and other drugs like sthira, bala, madhuka, ksheera which are balya, rasayana, and vata shamaka. 
       
                      Initially subjects diagnosed with osteoporosis are screened according to the inclusion and exclusion criteria. Selected patients are  posted for basti line of management for 16 days. Till the next follow up which is on 48th day the subject is given with placebo(starch filled capsule) to keep the subject in touch with the study.
Followup will be done on the 16th and 48th day . 
 
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