| CTRI Number |
CTRI/2023/09/057956 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of two Medicines Varatika Bhasma and Abha Guggulu in Osteoporosis |
|
Scientific Title of Study
|
A Comparative Clinical Study of Varatika Bhasma and Abha Guggulu in the Management oF Osteoporosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaykishan |
| Designation |
Postgraduation scholar |
| Affiliation |
Shri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,Room no 17, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7019271288 |
| Fax |
|
| Email |
jaysahubams968@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Moharana |
| Designation |
Professor |
| Affiliation |
Shri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,Room no 17, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123608 |
| Fax |
|
| Email |
drpkm@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Jaykishan |
| Designation |
Postgraduation scholar |
| Affiliation |
Shri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,Room no 17, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
07019271288 |
| Fax |
|
| Email |
jaysahubams968@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, 600123
Department Of Kayachikitsa Opd |
|
|
Primary Sponsor
|
| Name |
Dr Jaykishan |
| Address |
Department of Kayachikitsa, Room no 17, Sri Jayendra Saraswathi
Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai |
| 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 |
| Dr Jaykishan |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Department Of Kayachikitsa, Room No – 17, Sri Jayendra
Saraswathi Ayurveda College and Hospital, Nazarathpee, Poonamallee, Chennai
Thiruvallur
TAMIL NADU |
7019271288
jaysahubams968@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sri jayendra Saraswati Ayurveda College and hospital, Department of Ayurveda SCSVMV,Nazarethpet, Chennai -600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M800||Age-related osteoporosis with current pathological fracture. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abha guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varatika Bhasma, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Bhasma, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients were selected between the age group of 40-70 years
2.Patients of Osteoporosis diagnosed by B.M.D test (t-score < -2.5)
3.Patients having clinical features of osteoporosis - Extreme fatigue, Body pain, Pain in back, Pain in vertebra, Hip, distal forearm, tibia, Hair loss, Dorsal kyphosis, Fracture after minimal trauma |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 40 years and above the age of 70 years
2.Patients suffering from pathological Osteoporosis and neoplasms of the bone like osteoma and osteosarcoma
3.Hypercalcemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in Bone Mineral Density |
On day 91 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/10/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoporosis is defined as a reduction in the strength of bone that leads to an increased risk of fractures. Loss of bone tissue is associated with deterioration in skeletal micro-architecture. condition is particularly common in elderly people and more frequent in postmenopausal women. World Health Organization defines osteoporosis as “A disease characterized by low bone mass and micro-architectural deterioration of bone tissue, leading to enhanced bone fragility and a consequent increase in fracture risk.In osteoporosis, there is a long latent period before clinical symptoms develop. The most prevalent complications are fractures of vertebral bodies, ribs, proximal femur, humerus, and distal radius with minimal trauma. Varatika Bhasma is mentioned in Bhaishjya Ratnavali in Bhagna Roga Adhikara. Varatika Bhasma (Cypraea moneta Linn) is Katu Rasa, Rooksha-Tikshna Guna, Ushna Virya, Katu Vipaka, and Vatahara. Abha Guggulu is mentioned in Bhaishjya Ratnavali in Bhagna Adhikara.Ingredients of Abha Guggulu- Babul, Haritaki, Vibhitaki, Amalaki, Maricha, Pippali, Sunthi, Guggulu, GhritaAbha Guggulu is the predominance of Katu rasa, Laghu-Ruksha-Tikshna Guna, Ushana virya, Madhura Vipaka, and Karma are Vatahara, Rasayana, Vayahsthapana. |