| CTRI Number |
CTRI/2024/12/078336 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with Levothyroxine in the management of Primary Hypothyroidism |
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Scientific Title of Study
|
An Open Randamised Controlled Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with levothyroxine in the management of Primary 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 Pranay Omprakash Gundewar |
| Designation |
PG Scholar |
| Affiliation |
R.A. Podar hospital, worli |
| Address |
OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18
Mumbai MAHARASHTRA 400018 India |
| Phone |
8308068834 |
| Fax |
|
| Email |
pranaygundewar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunil Anandrao Bhaskare |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 |
| Address |
OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18
Mumbai MAHARASHTRA 400018 India |
| Phone |
9819165638 |
| Fax |
|
| Email |
bhaskaresunil14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr sunil Anandrao Bhaskare |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 |
| Address |
OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18
Mumbai MAHARASHTRA 400018 India |
| Phone |
9819165638 |
| Fax |
|
| Email |
bhaskaresunil14@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.18,Kayachikitsa Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 pin code-400018 |
|
|
Primary Sponsor
|
| Name |
R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 |
| Address |
R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 Dr.Anie Besant Road Pin code-400018 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranay Omprakash Gundewar |
Mahadevi Anandilal Podar Govt Hospital |
OPD No.18,Kayachikitsa Department,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18,Dr Anie Besant Road, Pin code-400018 Mumbai MAHARASHTRA |
08308068834
pranaygundewar@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of institution,R A Podar Govt Ayu collage,Worli |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunadi gutika, Reference: Ashtanga hrudaya sutrasthana , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Levothyroxine | Dose:1.6mcg/kg for 3 months OD |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Signs and symptoms of primary hypothyroidism- gauravata, nidradhikya, agnimandya, Shram, khalitya.
2) Subjects who are willing to give written informed consent.
3) Serum T3 and T4 within normal range and Serum TSH level above 5.5µU/ml but
below 20 µU/ml.
|
|
| ExclusionCriteria |
| Details |
1)Secondary hypothyroidism, itrogenic hypothyroidism, post thyroidectomy.
2)Pregnant & lactating mothers
3)Uncontrolled Hypertension, Diabetes Mellitus, IHD, CVA.
4)Malignancy of Thyroid Gland
5)Any other metabolic or systemic disease conditions where other treatment is urgent
and was disturb the regimen. (HIV, Diabetes Cardiovascular disease, Tuberculosis etc.)
6)Patient having myxoedema coma.
7)Patients having Down’s syndrome, Turner’s syndrome, Klinefelter’sSyndrome will be
excluded.
8)Present history of any mental disorder.
9)Patient with acute and chronic gastritis, PR bleeding. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with
levothyroxine on Kshudhamandya (poor appetite), Malavstambha(constipation),
Shram(lethargy), gauravta (heavyness of the body), Khalitya (hairloss), Nidradhikya
(increased sleep), etc. symptoms of primary hypothyroidism.
2.To study the effect of Varunadi Gutika as an adjuvant therapy with levothyroxine
on serum TSH T3, T4 level |
For 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To review the Ayurvedic & Modern literature on Primary Hypothyroidism.
2)To correlate Rasdhatvagnimandya,Rasapradoshjanya vyadhi & Primary Hypothyroidism.
3)To assess the possible mode of action of Varunadi Gutika |
At 4th 8th & 12th week |
|
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Target Sample Size
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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
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Brief Summary
|
Ayurveda is one of the ancient health care system. Ayurveda promotes specific lifestyle changes and natural treatments to restore harmony between the body, mind, spirit, and environment. Ayurveda is a holistic tradition and way of life that can assist each of us In claiming and celebrating our ability for wellness. The guiding principles of Ayurveda, maintaining health in all situations and eras, justifies current requirements for past uses. Due to an increase in sedentary and unhealthy lifestyles, many people nowadays experience numerous metabolic problems, including primary hypothyroidism. Hypothyroidism is one of the burning issue now a days. An unusually low thyroid hormone level is one of the symptoms of hypothyroidism. It happens when the thyroid gland does not produce enough thyroxine. Each organ in the body may be impacted by thyroxine’s control over how the body uses energy. Thyroxine deficiency causes the body’s functions to slow down. It affects nearly every bodily function, therefore maintaining a healthy level of thyroid hormone is essential for good health. The prevalence rate of hypothyroidism in Mumbai is 9.45%. Thyroid disease affects women more often than men and affects roughly 5% of the population. Womens are affected approximately six time more frequently than men. Ayurveda states that the pathophysiology of hypothyroidism is mostly caused by agni’s improper activity. It can be correlated to the concept of mandagni in ayurveda. The pathogenesis process is eventually shown by abnormal jatharagni functioning, which then affects dhatwagni and, ultimately, results in the disease condition. Varunadi Gutika is a combination of 09 drugs, which are Varun, Bruhati, Kanthakari, Chitrak, Bilva, Shobhanjan, Shatavari, saireyak, karanja. All these drugs have Ushna, Tikshna, Deepana, Pachana and Grahi properties therefore it will reduce the symptoms of hypothyroidism comparing to ’mandagni’
Need of study: For the treatment of primary hypothyroidism, an efficient pharmaceutical preparation is required. As the hormone replacement therapy is only available way to treat the condition. There is flaw in this conventional treatment because it required prolonged use. With the chronicity of the disease, the gland functioning never improves, instead they become more and more inactive. Taking above in consideration, I have chosen my synopsis under title, “An Open Randomised Controlled Clinical Study to evaluate the efficacy of Varunaadi gutika as an adjuvant therapy with Levothyroxine in the management of primary hypothyroidism."
Number of patient- Group A: Study group -30 patient will be administered Varunadi gutika along with Levothyroxine. Group B: Control group-30 patient will receive only Levothyroxine.
Investigations- CBC, ESR, BSL fasting and PP, Liver Function and Renal Function Test, Lipid Profile to exclude any Pathology. Thyroid function test , BSL and Lipid profile will be estimated before and after treatment.
Summary and Conclusion: The work will be summarized to make final conclusions Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
Expected outcomes: • Changes in subjectives by ’Varunadi Gutika’ towards reduction in previous severity. • Changes in Thyroid profile by ’Varunadii Gutika’ towards reduction of Sr.TSH in previous high levels. • Effect of ’Varunadi Gutika’ could be more than the effect of Tab.Levothyroxine without any adverse effects.
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