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CTRI Number  CTRI/2024/11/076410 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Comparative clinical study of three different ayurvedic formulations along with medicated enema in the patients of Osteoporosis 
Scientific Title of Study   A clinical study to evaluate and compare the effect of Trayodashanga Guggulu and Svayambhuva Guggulu with Laksha Guggulu along with Panchatiktaksheerabasti in the management of Asthikshaya. 
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 Sharanamma 
Designation  PhD Scholar 
Affiliation  Shri DGM Ayurvedic Medical College and Hospital Gadag 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Gadag

Gadag
KARNATAKA
582103
India 
Phone  7259826475  
Fax    
Email  dr.sharanamma24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharanamma 
Designation  PhD Scholar 
Affiliation  Shri DGM Ayurvedic Medical College and Hospital Gadag 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Gadag

Gadag
KARNATAKA
582103
India 
Phone  7259826475  
Fax    
Email  dr.sharanamma24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh N Belavadi  
Designation  Principal HOD Phd Guide  
Affiliation  Shri DGM Ayurvedic Medical College and Hospital Gadag 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Gadag

Gadag
KARNATAKA
582103
India 
Phone  9886916367  
Fax    
Email  hardikasnb@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri DGM Ayurvedic Medical college and Hospital Gadag Karnataka India PIN 582103 
 
Primary Sponsor  
Name  Dr Sharanamma 
Address  PhD scholar Shri DGM Ayurvedic medical college and Hospital PG PhD Studies and research center Gadag Karnataka 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharanamma   KPSVS ayurvedic medical College and hospital manvi raichur   Department of Kayachikitsa second floor room number 15 KPSVS ayurvedic medical College and hospital manvi sindanoor road manvi pin 584123
Raichur
KARNATAKA 		 7259826475

dr.sharanamma24@gmail.com 
Dr Santosh N Belavadi   Shri D G M Ayurvedic medical college and Hospital Gadag  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Gadag
Gadag
KARNATAKA 		 9886916367

hardikasnb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
KPSVS Ayurvedic Medical College and Hospital Manvi.  Approved 
Shri DGM Ayurvedic Medical College and Hospital Gadag  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
1Comparator ArmProcedure-kAla-bastiH, काल-बस्तिः (Procedure Reference: Ca su 28th chapter 27th sloka , Procedure details: Purvakarma -Deepanapachana - Haritakyadhi choorna 6grams twice a day along with ushnodaka anupana till niramalaxana followed by Abhyanga & swedana Pradhana karma- Anuvasanabasti with Panchatiktagrutha 100ml Niruhabasti with Panchatiktaksheerabasti 580ml Paschat karma -Bastipratyagamana Observation of yoga and atiyogalaxan and pathyapathya )
(1) Medicine Name: Trayodashanga guggulu , Reference: Bhaishajya Ratnavali 26th chapter 27th verse-98-101, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 45 Days
2Intervention ArmProcedure-kAla-bastiH, काल-बस्तिः (Procedure Reference: Ca su 28th chapter 27th sloka , Procedure details: Procedure details: Purvakarma -Deepanapachana - Haritakyadhi choorna 6grams twice a day along with ushnodaka anupana till niramalaxana followed by Abhyanga & swedana Pradhana karma- Anuvasanabasti with Panchatiktagrutha 100ml Niruhabasti with Panchatiktaksheerabasti 580ml Paschat karma -Bastipratyagamana Observation of yoga & atiyogalaxan and pathyapathya)
(1) Medicine Name: Lakshaguggulu , Reference: YogaRatnakara bhagnarogadhikara verse 23 , Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 45 Days
3Comparator ArmProcedure-kAla-bastiH, काल-बस्तिः (Procedure Reference: Ca su 28th chapter 27th sloka , Procedure details: Purvakarma -Deepanapachana haritakyadhi choorna 6grams twice a day along with ushnodaka anupana till niramalaxana followed by Abhyanga & swedana Anuvasanabasti with Panchatiktagrutha 100ml Niruhabasti with Panchatiktaksheerabasti 580ml Paschat karma -Bastipratyagamana Observation of yoga and atiyogalaxan Pathyapathya.)
(1) Medicine Name: Svayambhuva guggulu , Reference: Vangasenasamhita vatarogadhikara sloka 226-229, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 45 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Subjects complaining of classical symptoms of Asthikshaya- Asthishoola,Sandhishoola, Keshapatana, Dantavikara,Nakhavikara and Osteoporosis-Backpain,Jointpain will be included.
2)Subjects between the age group of 40-70years of either sex.
3)Subjects of Osteopenia and Osteoporosis diagnosed by Bone Mineral Density test.
4)Subjects with BMD score below -1(minus).
5)Subjects fit for Basti Karma.(scheduled treatment protocol). 
 
ExclusionCriteria 
Details  1)Subjects associated with Hypertension, Diabetic mellitus and other systemic disorders.
2)Subjects associated with Secondary Osteoporosis.
3)Pregnant women and lactating women.
4)Subjects with one or more fragility fracture. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Know the effects of intervention on BMD t score and Laxana of Asthikshaya  base line -36th day-66th day-96th day  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate if the Asthikshaya condition is reversible based on subject parameters like Asthishoola,sandhishoola,keshapatana,nakhadantapatana through Bastikarma & Shamanoushadhi.
To standardize the safe & effective ayurvedic line of management in asthikshaya in comparison to established drug in contemporary medicine based on subject parameters like Asthishoola,sandhishoola,keshapatana,nakhadantapatana. 		 12 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/11/2024 
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="2"
Months="8"
Days="23" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Stastical test repeated ANNOVA).

  6. For how long will this data be available start date provided 24-10-2028 and end date provided 26-09-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary   Asthikshaya is Explained in Astadasha Kshaya by Acharya Charaka. Asthikshaya symptoms described in different Samhita are Asthibheda,Asthishoola, Kesha, loma,nakha, smashrudanta vikara, Sandhishaithilya and rukshata. As explaination of Asthikshaya is Analogous with description of Osteopenia and Osteoporosis in contemporary science and often reffered as the Silent Disease. It is considered as serious disabling disease of public health concer. Osteoporosis is disease the second most common metabolic bone and aslo degenerative disease that leads to an increased risk of fractures,but only a small proportion are diagnosed and treated. Modern drugs used for the treatment and have serious adverse effects.Hence there is a need of better and safe cost effective management of Asthikshaya, thus Study is "A CLINICALl STUDY TO EVALUATE AND COMPARE THE EFFECT  OF TRAYODASHANGA GUGGULU  AND SVAYAMBHUVA GUGGULU WITH  LAKSHA GUGGULU ALONG WITH  PANCHATIKTAKSHEERABASTI IN THE MANAGEMENT OG ASTHIKSHAYA."




HYPOTHESIS- Total no of subject..........120

Group A....(Lakshaguggulu with Panchatiktaksheerabasti) 40 subjects

Group B....( Trayodashangaguggulu with Panchatiktaksheerabasti) 40 subjects

Group c.....( svayambhuvaguggulu with Panchatiktaksheerabasti ) 40 subjects

Null Hypothesis - H0 - Group B and Group C are not having significant effect than Group A

Alternative Hypothesis-H1- Group B and Group C are having significant effect than Group A

Alternative Hypothesis- H2- Group B has Significant effect more than Group A

Alternative Hypothesis-H3- Group C has Significant effect more than the Group A.



VALUES.. 40+40+40= 120 is the Subjective values in the study.
 
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