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CTRI Number  CTRI/2023/07/055298 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Asthisamharadi churna in the management of Osteoporosis in Perimenopuase women.  
Scientific Title of Study   “A RANDOMIZED OPEN – LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASTHISAMAHAARAADI CHURNA IN ASTHI KSHAYA w.s.r OSTEOPENIA AND OSTEOPOROSIS OF PERIMENOPAUSE”  
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 Inchara P 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr depatment opd room no 10
Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10
Bangalore
KARNATAKA
560085
India 
Phone  9986342595  
Fax    
Email  incharap.456@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharon Samuel 
Designation  Associate proffessor 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10
Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10

KARNATAKA
560082
India 
Phone  9884832050  
Fax    
Email  sharon.avp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Inchara P 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10
Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10

KARNATAKA
560085
India 
Phone  9986342595  
Fax    
Email  incharap.456@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital Bengaluru 560082 
 
Primary Sponsor  
Name  Dr Inchara P 
Address  Sri sri ayurveda hospital Near Art of living kanakapura main road Udaipalya 21st km post ptsr department opd room no 10 
Type of Sponsor  Other [self] 
 
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 Inchara P  Sri Sri College of Ayurvedic Science and Research  ptsr department opd room no 10
Bangalore
KARNATAKA 		 9986342595

incharap.456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri College of Ayurvedic Science and Research  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 ArmDrugClassical(1) Medicine Name: Asthisamharadi churna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Ghee and Milk), Additional Information: -
2Comparator Arm (Non Ayurveda)-Calcium and Vitamin Calcium 500mg and Vitamin D 500IU
 
Inclusion Criteria  
Age From  36.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Subjects showing signs of menopause i.e. stage -2 (early menopause stage) and stage -1 (late menopause stage) of STRAW classification.
2. Subjects complaining symptoms like : joint pain, back ache, pain in bones (which will be later confirmed by BMD)
3. Subjects having BMD score ( T score < - 1 SD )
 
 
ExclusionCriteria 
Details  1. Subject aged less than 35 years and above 55 years.
2. Subjects undergoing HRT.
3. Subjects of known case of Renal calculi.
4. Subjects of known case of Osteomalacia, Rickets.
5. Subjects of known case of Thyroid dysfunction.
6. Subjects of known case of IHD.
7. Subjects having BMD score (‘T’ score less than - 2.5 SD with fracture).
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in the BMD score  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in tiredness, weakness of joint, back ache  90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   25/07/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
  • Perimenopause is  an ill-defined time period that surrounds the final years of a woman’s reproductive life. It begins with the first onset of menstrual irregularity and ends after 1 year of amenorrhea has occurred, thereby defining the final menstrual period
  • During this transition, women experience multitude of symptoms that may not be life-threatening but have a negative impact on the quality of life, physical and mental health
  • Out of 230 million Indians expected to be over age of 50 years in 2015, 20%, ie, ~46 million, were women with osteoporosis
  •  Asthisamhaaraadi Churna  is a formulation used in Asthi Kshaya with qualities like Vatahara and Balya in Jara, which could prove to be beneficial in the management of the same
 
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