| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Intervention Arm | Drug | Classical | | (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: - | | 3 | Intervention Arm | Drug | Classical | | (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: - | | 4 | Intervention Arm | Procedure | - | 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 | | 5 | Intervention Arm | Procedure | - | 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.
|