| CTRI Number |
CTRI/2025/04/085019 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of Siddhant Nyunan Dhatun Purayam with special referance to Asthikshay in post menopausal women |
|
Scientific Title of Study
|
Conceptual and clinical study of siddhant Nyunan Dhatun Purayam with special reference to Asthikshaya in post-menopausal women
|
| 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 Pallavi Raosaheb Puppalwad |
| Designation |
P.G. STUDENT |
| Affiliation |
R.A.PODAR.AYURVEDIC MEDICAL COLLEGE |
| Address |
Deparment of Samhita and Siddhant ,OPD NO.9, R.A.PodarAyurvedic Medical College and Hospital,Dr.Anne Besant Road, Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9623737745 |
| Fax |
|
| Email |
puppalwadpallavi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Sabu |
| Designation |
Head of department |
| Affiliation |
R.A.PODAR.AYURVEDIC MEDICAL COLLEGE |
| Address |
Department Of Samhita And Siddhant,OPD NO.9,R.A.Podar Ayurved Medical College And Hospital,Dr.Anne Besant Road,Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9869399393 |
| Fax |
|
| Email |
narayansabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Sabu |
| Designation |
Head of department |
| Affiliation |
R.A.PODAR.AYURVEDIC MEDICAL COLLEGE |
| Address |
Department of Samhita And Siddhant,OPD No.9,R.A.Podar Ayurvedic Medical College And Hospital,Dr.Anne Besant Road, Worli,Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9869399393 |
| Fax |
|
| Email |
narayansabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Hospital,Dr.Anne Besant Road,Worli,Mumbai,400018,India
|
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Raosaheb Puppalwad |
| Address |
R.A.PODAR.AYURVEDIC MEDICAL COLLEGE,DR.ANNE BESANT ROAD, WORLI,MUMBAI |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Pallavi Raosaheb Puppalwad |
Mahadevi Anandilal Podar Govt. Hospital |
Department of Samhita And Siddhant, OPD NO.9,R.A.Podar Ayurvedic Medical College And Hospital,Dr Anne Besant Road,Worli,Mumbai
Mumbai
MAHARASHTRA |
09623737745
puppalwadpallavi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee R.A. Podar Ayurvedic Medical College ,Worli,Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
AGE BETWEEN 45 TO 70 |
| 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 | Drug | Classical | | (1) Medicine Name: Panchtikta Ghrut Guggul vati, Reference: Bhaishajya ratnavali chapter 54 verse 3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -anupan-with warm water |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Post Menopausal Women With Controlled Hypertension ,Able And Willing To Give Written Informed Consent. |
|
| ExclusionCriteria |
| Details |
Womem With Menopause caused due to Hysterectomy ,Known case of Hyperthyrodism , Tuberculosis of Bone Osteomalacia & Any Genetic Disorder,Patient with CKD(CHRONIC KIDNEY DISEASE),Patient with R.A. Gouty Arthritis and Any Other Chronic Systemic Disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Asthikshaya Symtoms |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
21/04/2025 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Salection of post menopausal women diagnosed with Asthikshay .Inclusion and exclusion will be done.55 patients will be selected. The Patient will be given panchtikt ghrut guggul vati. During treatment patient will be called on 30th ,60 th ,90, day for confirmation of regular medication and for assessing Asthishool ,sandhishool ,balkshay , kesh nakh patan ( hair fall ) , katishool. Assesment will be taken. Objective criteria -1) serum calcium 2) vitamin D Subjective criteria - (VAS )Visual analogue scale content of panchtikta ghrut guggul-Nimba,Amrita,Vasaka,Patola,Nidigdhika,Water,Purified guggulu, murcchita cow ghritam,patha,vidanga,suradaru,gajapippali,yavksara,svarjiksarta,sunthi,haridra,aniseeds,chavya,kustha,tejovati,maricha,vatsaka,dipyaka,chitraka,rohini,aruskara,vaca,pippalimula,manjistha,haritaki,vibhitaka,amalaki and yavani Aushadhi Sevan kal- vyano udan kal Aushadi matra-6gms/day Anupan-with warm water(Koshna jal)
Collection, classification, presentation of data,statistical analysis and conclusion will be drawn |