CTRI Number |
CTRI/2023/10/058711 [Registered on: 16/10/2023] Trial Registered Prospectively |
Last Modified On: |
20/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To Study Add On Effect Of Varunmoola Kwath Ghana Vati With Thyroxine In Hypothyroidism. |
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate Add On Effect Of Varunmoola Kwath Ghana Vati With Thyroxine In 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 |
Dr Ankush Rajkumar Patle |
Designation |
PG Scholar |
Affiliation |
PDEAs Of Ayurved And Research Centre Nigdi PuneCollege |
Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune
Maharashtra
411044
India
Pune MAHARASHTRA 411044 India |
Phone |
7028880058 |
Fax |
0 |
Email |
ankushpatle27@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Medha M Joshi |
Designation |
Professor & HOD |
Affiliation |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune |
Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune
Maharashtra
411044
India
Pune MAHARASHTRA 411044 India |
Phone |
8104332338 |
Fax |
0 |
Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Medha M Joshi |
Designation |
Professor & HOD |
Affiliation |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune |
Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune
Maharashtra
411044
India
Pune MAHARASHTRA 411044 India |
Phone |
8104332338 |
Fax |
0 |
Email |
medhamaheshjoshi@gmail.com |
|
Source of Monetary or Material Support
|
PDEAs College of Ayurved and Research Center nigdi pune |
|
Primary Sponsor
|
Name |
PDEAs College Of Ayurved And Research Centre Nigdi Pune |
Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune
Maharashtra
411044
India |
Type of Sponsor |
Private medical college |
|
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 Ankush Patle |
Ayurved Rugnalaya And Sterling Multispeciality hospital Pune |
Ayurved Rugnalaya And Sterling Multispeciality hospital Sector No 27 Kayachikitsa Department Opd no 117 Nigdi Pradhikaran Pune 411044 Pune MAHARASHTRA |
7028880058 0 ankushpatle27@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunmoola Kwath Ghanavati , Reference: Vangasen Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madh), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Diagnosed cases of Hypothyroidism on the basis of TSH Levels (TFT will be done)
2) Patients S.TSH level above normal value and involving symptoms of hypothyroidism from subjective criteria (puffiness of face, oedema, dry and coarse skin, breathlessness, constipation, fatigue, hair fall)
3) Age between 20 to 60 years. |
|
ExclusionCriteria |
Details |
1)Pregnancy, lactating mother
2)patient having associated diseases as ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes, known case of MI, Cerebrovascular events, cardiac arrhythmias, malignancy, hyperthyroidism
3) patients with any known infective disease
4) known case of major systemic diseases such as TB, AIDS, IHD, CA, Renal and cerebral diseases, thyroid CA, partial thyroidectomy, congenital thyroid disorders and other major endocrinal disease, morbidly obese patients |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1.To Study efficacy of Varunmoola kwath Ghanavati with Thyroxine in the management of hypothyroidism for 60 days.
2.To give maximum symtomatic relief to patient after 60 days of treatment. |
60 days study with four follow ups on 15th,30th,45th and 60th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
To observe adverse drug reaction if any. |
60 days study
follow up at 15th, 30th, 45th 60th day |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
28/10/2023 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Non Communicable diseases are the leading cause of adult mortality and morbidity worldwide. Hypothyroidism is a metabolic disorder as it involves the underproduction of hormones that play a role in metabolism Hypothyroidism is believed to be a common health issue in India, as it is worldwide. The most common presentations of thyroid disorders are hypothyroidism, hyperthyroidism,and enlargement if thyroid gland. widespread availability of thyroid function tests has led to the increasingly frequent identification of patients with abnormal results who either are asymptomatic or have non-specific complaints such as tiredness and weight gain.Untreated hypothyroidism can lead to a number of health issues, Heart problems, Mental health issues (Depression), Peripheral neuropathy, Myxoedema, Infertility, Birth defects3. 42 million people in India have thyroid disorders and hypothyroidism is the most common of thyroid disorders in India, affecting one in ten adults.The prevalence of hypothyroidism in India is 11%, compared with only 2% in the UK and 4·6% in the USA4.Over 8% of Indian is at a higher future risk of getting affected, and 1/3rd of the hypothyroid patients is unaware of the condition Reduced Production of thyroid hormone is the central feature of the clinical state termed hypothyroidism. Primary hypothyroidism which is due to disease of thyroid itself ,accounts for approximately 99% of cases, with less than 1% being due to TSH deficiency known as central or secondary hypothyroidism.In adult hypothyroidism clinical features can largely be explained by the reduced metabolic rate and symptoms of hypothyroidism develop gradually. Skin is pale and cool and reduction in sweat and sebaceous secretion causes dryness and coarseness, decrease in exercise tolerance , cold intolerance, weight gain. In modern medicine the treatment for hypothyroidism is the administration of thyroxine in the form of tablet, orally. Acharya Charak emphasized that nomenclature of the diseases is not much important to treat the diseases, rather he insists on diagnosis of the constitutional status and plan the treatment accordingly. On reviewing the clinical presentation from all classical texts it is found that in hypothyroidism there is abnormality of Jatharagniand Dhatwagni along with abnormality of Kapha and VataDosha as well as Rasavaha, Raktavaha,Medovaha, Shukravahaand Manovaha Srotases. Dosha-Dushyasamoorchhana in various Dhatus results in the systemic manifestation of the disease. Thus, the line of treatment involves Deepana, Pachana, SrotoshodhanaandKaphavata shamana8. At this present moment hormone replacement therapy is available for hypothyroidism, there is and there is need of time to find proper and efficient supportive Ayurvedic treatment modality for hypothyroidism ,Therefore i Have select this topic. For that I have choose to give VarunmoolaKwath GhanaVati orally along with Thyroxine. Thyroxine is used to treat an underactive thyroid gland (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland9, Therefore it will be taken as a control group. This varunmoola kwath ghanvati described in vangasen samhita. |