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CTRI Number  CTRI/2025/02/081090 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Insights into Silent Osteoporosis: Clinical Diagnosis and Management of Asthisaushirya - A Pilot Study 
Scientific Title of Study   Identification of the defining clinical characteristics of a silent disease in patients meeting the WHO Criteria of Osteoporosis(Asthisaushirya): An Ayurvedic Perspective on its clinical diagnosis and management- A Pilot Study  
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 Chanchal Kaoshik 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda, Delhi 
Address  7th Floor, Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  9971617097  
Fax    
Email  chanchalkaushik2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh Kumar Bhatted 
Designation  Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room no 703, Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  94140484459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chanchal Kaoshik 
Designation  MD Scholar 
Affiliation  All India Institute of Ayurveda  
Address  7th Floor, Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  9971617097  
Fax    
Email  chanchalkaushik2000@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi-110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  7th Floor, Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri Awas, Sarita Vihar, Delhi 
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 Chanchal Kaoshik  All India Institute of Ayurveda  OPD NO.6, Department of Panchakarma, Gautampuri, Sarita Vihar, Delhi-110076 South DELHI
South
DELHI 
09971617097

chanchalkaushik2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Division of Translational Research and Biostatistics, All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M810||Age-related osteoporosis without current pathological fracture. Ayurveda Condition: ASTHIKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pAcana, पाचन (Procedure Reference: Charaka Samhita Sutra Sthana, Procedure details: 3gm bd after food with lukewarm water for 3 days)
(1) Medicine Name: Vaishwanar Churna, Reference: Astanga hridya Chikitsa Sthana 14/34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 3 Days
2Intervention ArmDrugClassical(1) Medicine Name: Aswagandhadi Ghrita, Reference: Chakradutta, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Guduchi and Satavari sidhha Ksheera), Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Vaishwanar Churna, Reference: Astanga Hridya Chikitsa Sthana 14/34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
4Intervention ArmProcedure-kosthasudhhi (Procedure Reference: Charaka Samhita Sutra Sthana 11/48, Procedure details: after pachana for 3 days, kosthasudhhi done for 1 day with 15ml Ghandharhastadi Eranda oil in morning empty stomach)
(1) Medicine Name: Ghandharvahastadi Eranda Taila, Reference: Astanga Hridya Chikitsa sthana 15/21, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 1 Days
5Intervention ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: Charka Samhita sidhhi Sthana 12, Procedure details: after kosthasudhhi than yapana basti should be done for 8 days in the morning empty stomach)
(1) Medicine Name: Aswagandhadi Ghrita, Reference: Chakra dutta, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male or Female patients between the age group of 40 to 70 years.
2.gender both
3.Diagnosed case of primary Osteoporosis by BMD Test(T-score of less than or equal to -2.5).

4.Patients fit for basti and brumhana snehpana. 
 
ExclusionCriteria 
Details  1.DM (Diabetes mellitus)
2.Patients on long-term medications such as Steroids and antiepileptic drugs
3.Cancer patients
4.Surgical patients
5.Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Enlisting of the pathognomonic Ayurvedic Clinical characteristics of Osteoporosis(Asthisaushirya)   Day-0, Day-28, Day-58 and on follow up Day-88 
 
Secondary Outcome  
Outcome  TimePoints 
Compilation of the clinic-radiological results to the Ayurvedic treatment protocol for Osteoporosis(Asthisaushirya)  0th-Day, 88th-Day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   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 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  

Osteoporosis has been described as a ‘silent disease’ in modern literature. Just as other silent diseases like Hypertension and Hypercholesterolemia are identified by their terminal events of Stroke and CAD respectively, Osteoporosis is also identified by the occurrence of fragility fractures in the spine, hip and wrist in their natural history.[i] To circumvent the occurrence of such medical emergencies in these ‘silent diseases’, modern medicine evolved and recommends routine screening of vulnerable age groups with blood pressure (BP), lipid profile and bone mineral density (BMD) measurements.

 

      Osteoporosis is an anukt vyadhi (undescribed disease) in classic Ayurveda texts, though there are few references available in Brihattreyi Samhitas by the name of Asthisaushirya. Whereas Acharya Charak has described ‘Sushirta of Asthidhatu’ (porousness of bone) as a physiological process to make space for the Majjadhatu to rest in (Ch. Chi 15/31); Acharya Vagabhat, on the other hand, has alluded to a pathological process wherein Asthisaushrya has been described as one of the lakshanas (signs) of a clinical syndrome called Majjagata Vata (A.H.Su.11/19; A.H. Ni. 15/12). However, the Samhitas are silent about the clinical presentation of Asthisaushirya and there is no mention of clinical characteristics which can help the clinician to identify this lakshna in a patient.

 

      A review of the contemporary Ayurveda literature over the last 40 years on various search portals revealed that researchers on the subject have tended to equate Osteoporosis with Asthisashirya and have considered the vitiation of Vata in Asthi and Majja Dhatus (Asthimajjagata Vata) as the main Samprapti of the disease. While equating Osteoporosis with Asthisaushirya, the other associated signs and symptoms described along with Asthisaushirya in the relevant shlokas, such as severe pain, sleeplessness, falling of teeth, hairs, and nails etc. have been largely ignored by the workers. Clearly, these researchers are not describing the silent disease Osteoporosis which has a set WHO criteria of BMD ≤ 2.5. Thus, their equation of these two terms Osteoporosis and Asthisashirya is not justified in the light of the present clinical and literary evidence.

Apropos of the discussion above, and on the strength of their clinical experience, the researchers of the present study believe that Osteoporosis has been labelled a ‘silent disease’ not because it is silent, but because the modern clinical methods employed to read the symptomatology of this disease were not sensitive enough. Hence, the need for identifying the defining clinical characteristics of this silent disease in patients meeting the WHO criteria of Osteoporosis, employing the more subtle clinical methods described in classic Ayurveda texts, is strongly felt. The proposed study is a small step in that direction and is also expected to establish the clinical presentation of Asthisaushirya.

 



 

 
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