Clinical Trial Details (PDF Generation Date :- Thu, 23 Aug 2018 03:29:00 GMT) CTRI Number Last Modified On 05/11/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/11/005185 [Registered on: 07/11/2014] - Trial Registered Retrospectively Yes Interventional Siddha Single Arm Trial A clinical trial to study the effects of a Polyherbal Siddha drug, "Atthippattaiyathi Kasayam" in patients with Type 2 Diabetes Mellitus (Mathumegam). Preclinical and Clinical study on MATHUMEGAM (Type-2 Diabetes Mellitus) and the drug of choice is ATTHIPPATTAIYATHI KASAYAM (Internal). Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr Senthil kumar S G Phone 9994172837 PG Scholar, Branch - I, Department of Maruthuvam (Medicine) drsgsen@gmail.com Details Contact Person (Scientific Query) Dr H Nalini Sofia Phone 9677777677 Lecturer, Department of Maruthuvam (Medicine) dr.h.nalinisofia@gmail.com Details Contact Person (Public Query) Dr H Nalini Sofia Phone 9677777677 Lecturer, Department of Maruthuvam (Medicine) dr.h.nalinisofia@gmail.com page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria > Ayothidoss Pandithar Hospital, Chennai. Type of Sponsor List of Countries of Principal Investigator Dr Senthil kumar S G Source of Monetary or Material Support Primary Sponsor Details national institute of siddha tambaram sanatorium, chennai-47. Research institution and hospital of Site Site Phone// Ayothidoss Pandithar Hospital, Out Patient Room Number:1, Department of Maruthuvam (Medicine), National Institute of Siddha, Tambaram Sanatorium, Chennai-47. 9994172837 drsgsen@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethical Committee, National Institute of Siddha Status Not Applicable Health Type Patients Approved 24/12/2011 No Date No Date Specified Condition Mathumegam (Type-2 Diabetes Mellitus) Type Details Intervention Atthippattaiyathi Kasayam 336 ml (Internal) TID for 40 Days Comparator Agent Age From Age To Gender Details Details 30.00 Year(s) 55.00 Year(s) Both Inclusion Criteria Polyuria, Nocturia, Polydipsia, Polyphagia, Body pain, Weight gain(obesity), Tiredness, Burning feet, genital pruritus, Diabetes defined as those patients with Fasting plasma glucose level 126 to 180 mg/dl, 2 hours postprandial plasma glucose level 200 to 300 mg/dl Exclusion Criteria IDDM, Diabetic complications like microvascular and macrovascular page 2 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Other Open Label complications etc, Cardiac diseases, Pulmonary diseases, Renal diseases, Thyroid dysfunctions, Gestational diabetes, Other endocrine abnormalities, Patient who are not willing to give blood sample Primary Outcome Outcome Timepoints Primary outcome: 40 days The outcome is mainly assessed by comparing the pre and post treatment blood glucose level of the trial patient. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary secondary outcome is assessed by comparing the pre and post siddha and clinical parameters and investigation parameters like lipid frofile. Total Sample Size=40 Sample Size from =40 22/07/2012 No Date Specified Years=0 Months=5 Days=22 Not Applicable Completed 40 days This study was an open clinical trial to evaluate the therapeutic efficacy of siddha polyherbal formulation Atthippattaiyathi Kasayam, 336 ml three times daily for 40 days duration in 40 patients with type 2 Diabetes mellitus, that was conducted in one center in. The primary outcome was mainly assessed by comparing the pre and post treatment blood glucose level of the trial patients. Secondary outcome was assessed by changes in siddha and clinical parameters and changes in investigation parameters like lipid profile. The constituents of Atthippattaiyathi Kasayam containing 22 raw drugs of herbal origin. They are, 1. Ficus racemosa (Bark)- 70gm 2.Cassia fistula (Bark)- 70gm page 3 / 5
3. Cassia auriculata (Bark)- 70gm 4. Salacia reticulata (Root bark)- 70gm 5. Madhuca longifolia (Bark)- 70gm 6. Tamarindus indica (Bark)- 70gm 7. Terminalia arjuna (Bark)- 70gm 8. Spermacose hispida (Root)- 70gm 9. Citrus medica (Root)- 70gm 10. Hemidesmus indicus (Root)- 70gm 11. Amaranthus tricolor (Root)- 70gm 12. Phyllanthus reticulatus (Root)- 70gm 13. Aloe barbadensis (Root)- 70gm 14. Cyperus rotundus (Root tuber)- 70gm 15. Tinospora cordifolia (Stem)- 70gm 16. Zingiber officinale (Rhizome)- 70gm 17. Piper nigrum (Dried Fruit)- 70gm 18. Piper longum (Dried fruit)- 70gm page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial 19. Abies spectabilis (Leaf)- 70gm 20. Myristica fragrans (Aril)- 4.2gm 21. Syzygium aromaticum (Dried flower bud)- 4.2gm 22. Ferula asafoetida (Gum oleoresin)- 4.2gm a) Atthippattaiyathi Kasayam powder preparation method- All the purified raw drugs are mixed well and ground into a coarse powder by using iron mortar and pestle and stored in clean and dry wide mouthed glass bottles. b) Atthippattaiyathi Kasayam preparation method- Take 5 gm of above Atthippattaiyathi Kasayam powder and add 1.3 liter of water and boil it to reduce one fourth of the part that is 336 ml. page 5 / 5