| CTRI Number |
CTRI/2024/02/062611 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative clinical trial to evaluate the efficacy between Kanchanar kwath with Sunthi churna and Varuna kwath with Madhu in the management of Galaganda (Hypothyroidism). |
|
Scientific Title of Study
|
Preclinical and Clinical Study of Kanchanar Kwath with Sunthi Churna and Varuna Kwath with Madhu in Galaganda Rogadhikar w.s.r. to Hypothyroidism. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIT KUMAR TARAPHDAR |
| Designation |
READER (DRAVYAGUNA) |
| Affiliation |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P. |
| Address |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION & RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA-700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KOYEL DEY |
| Designation |
MD second year |
| Affiliation |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P. |
| Address |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA, 700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
6290070863 |
| Fax |
|
| Email |
drkoyel1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KOYEL DEY |
| Designation |
MD second year |
| Affiliation |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P. |
| Address |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA, 700009.
WEST BENGAL
700009
India |
| Phone |
6290070863 |
| Fax |
|
| Email |
drkoyel1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA-700009.
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P. |
| Address |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA, 700009.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| KOYEL DEY |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P. |
INSTITUTE OF POST GRADUATE AYURVEDIC EDUCATION AND RESEARCH AT S.V.S.P.
294/3/1, A.P.C. ROAD, KOLKATA 700009.
Kolkata
WEST BENGAL |
6290070863
drkoyel1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR CLINICAL TRIAL ON HUMAN SUBJECTS I.P.G.A.E AND R AT S.V.S.P. KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KANCHANAR KWATH WITH SUNTHI CHURNA, Reference: SHARANGADHAR SAMHITA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -HOT WATER), Additional Information: -(2) Medicine Name: VARUNA KWATH WITH MADHU, Reference: SHARANGADHAR SAMHITA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS HAVING SYMPTOMS OF GALAGANDA (HYPOTHYROIDISM) WILL BE SELECTED FROM OPD AND IPD. DRY SKIN, WEIGHT GAIN, PERIORBITAL PUFFINESS, COLD INTOLERANCE, SLOW MOVEMENT, DIMINISHED SWEATING |
|
| ExclusionCriteria |
| Details |
PATIENTS BELOW 20 AND ABOVE 60 YEARS OF AGE. PATIENTS HAVING HYPERTHYROIDISM, BRITTLE NAIL, HIGH CHOLESTEROL, SLUGGISHNESS, NEOPLASTIC GOITRE, TUBERCULOSIS, DIABETIC MELLITUS, HIV, HBSAG, PREGNANT WOMEN, LACTATING MOTHER |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MEAN PERCENTAGE DECREASE IN TSH AND INCREASE IN T3 AND T4 LEVEL FROM THE BASE LINE TO THE END OF THE STUDY |
MEAN PERCENTAGE DECREASE IN TSH AND INCREASE IN T3 AND T4 LEVEL FROM THE BASE LINE TO THE END OF THE STUDY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RELIEF FROM THE CLINICAL FEATURES OF THE GALAGANDA (HYPOTHYROIDISM)
DRY SKIN, WEIGHT GAIN, PERIORBITAL PUFFINESS, COLD INTOLERANCE, SLOW MOVEMENT, DIMINISHED SWEATING |
UPTO 30 DAYS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="1"
Months="0"
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
|
A research work entitled “Preclinical and Clinical Study of Kanchanar Kwath with Sunthi Churna and Varuna Kwath with Madhu in Galaganda Rogadhikar w.s.r. to Hypothyroidism†was undertaken, as a part fulfillment of MD(Ayu.) study under The west Bengal university of health sciences. Now a days Galaganda (Hypothyroidism) is a very common endocrinal disorder in our society. Two research formulations in this comparative study are "Kanchanar kwath (decoction) with Sunthi churna" and "Varuna kwath (decoction) with Madhu (Honey)" which are mention in "Sharangadhar Samhita" Madhyam Khanda for the treatment of Galaganda (Hypothyroidism). Acharya Chakrapanidatta and Bhavmishra also mentioned those two formulations in the treatment of Galaganda (Hypothyroidism). |