| CTRI Number |
CTRI/2024/08/071783 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sub-Clinical Hypothyroidism Management In Ayurveda |
|
Scientific Title of Study
|
Effect Of Makandi (Coleus Forskohli Briq.) Moola Churna Capsule In The Management Of Subclinical Hypothyroidism–An Open Labeled Clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddhayya Swami |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyala Shahapur Belagavi Karnataka-590003 |
| Address |
Dept of Dravyaguna
KAHERs Shri B M K Ayurveda Mahavidyalaya
Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9588602396 |
| Fax |
|
| Email |
siddhayyaswami1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Chougale |
| Designation |
Professor And HOD |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyala Shahapur Belagavi Karnataka-590003 |
| Address |
Dept of Dravyaguna
KAHERs Shri B M K Ayurveda Mahavidyalaya
Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arun Chougale |
| Designation |
Professor And HOD |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyala Shahapur Belagavi Karnataka-590003 |
| Address |
Dept of Dravyaguna
KAHERs Shri B M K Ayurveda Mahavidyalaya
Shahapur Belagavi Karnataka India
Belgaum KARNATAKA 590003 India |
| Phone |
9964749993 |
| Fax |
|
| Email |
punarjeevam@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education & Research Ownes by Shri BMK Ayurveda Mahavidyalay Shahapur Belagavi 590003 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr. Siddhayya swami |
| Address |
Dept of Dravyaguna
KAHERs Shri B M K Ayurveda Mahavidyalaya
Shahapur Belagavi Karnataka-590003 |
| Type of Sponsor |
Other [Self Sponsered PG disertation work] |
|
|
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 Siddhayya Swami |
KLE Ayurveda hospital And PG Research Centre Shahapur Belagavi |
Department of dravyaguna Speciality OPD NO 3 KLE Ayurveda hospital And PG Research Centre Shahapur Belagavi Belgaum KARNATAKA |
9588602396
siddhayyaswami1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| lnsitutional Ethics Committee for Research on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MAKANDI (COLEUS FORSKOHLI BRIQ.) MOOLA CHURNA CAPSULE , Reference: RAJ NIGHANTU & SHALIGRAM NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Makandi Moola Churna Capsules will be
prepared and given .
Single Drug Therapy |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient not on any Anti-thyroid medication
2 Where TSH value is above normal value 4.5mIU/L
but below 10mIU/L
3 Individuals of either sex between the age group of
18 to 60 years fulfilling diagnostic criteria of
subclinical hypothyroidism |
|
| ExclusionCriteria |
| Details |
1 Patient on Anti-thyroid medication.
2 Serum TSH value more than 10mIU/L.
3 Subjects with congenital hypothyroidism & Subjects who have
undergone thyroid surgery.
4 Patients with complications of hypothyroidism like cardio vascular
disorders, infertility, Myxedema coma etc.
5 Patients with alcohol dependency or drug dependency.
6 Pregnant or lactating women.
7 Patients suffering from major systemic illness and long term drug
treatment Rheumatoid arthritis etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Thyroid profile |
0th day and 42th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight Loss and Inch loss in Waist circumference,Mid-Thigh and Mid-arm circumference |
0th,15th ,30th,42nd day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="6" 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
|
Thyroid gland diseases are the most abundant endocrine
disorder after Type 2 Diabetes Mellitus in terms of prevalence. Hypothyroidism
affects 6.4% of the 42 million thyroid disorder patients in India and 200
million worldwide, making it the most common. There is no universal consensus
on the management of subclinical hypothyroidism. Some practitioners prescribe
low-dose levothyroxine, which can cause adverse symptoms such as anxiety,
increased appetite, irritability, and mood swings.
Sub Clinical Hypothyroidism typically develops slowly and
initial symptoms are often nonspecific and diffuse. It’s not uncommon for the
diagnosis to be overlooked. However, the physical changes that come with the
illness are characteristic: dry, rough skin; pale and puffy complexion; hair
loss; change in voice; decreased appetite; and menstrual abnormalities, etc.
Makandi (Coleus forskohli Briq) has the Rasa
qualities of Tikta, Katu and Madhur, along with Tikshna and
Vikasi guna. Its virya is Ushna, and Vipak is Madhur.
The active ingredients in Coleus Forskolin include
Diterpene, Forskolin (coleonols) and Volatile oils.
In a one study it is stated that, chronic treatment of
cultured thyroid cells with forskolin sensitizes adenylate cyclase response to
acute stimulation by forskolin or thyrotropin (TSH). This positive regulation,
similar to that produced by TSH, occurs between 2 and 3 days of culture.
“Give a Drug as a Wholeâ€, As a fundamental element of Pada
Chatushtaya, drugs play a crucial role in treatment efficacy, contingent
upon appropriate dosage and formulation. Modern scientific progress has
popularized the use of extracts and isolated compounds. Ayurveda’s Rasa
Panchaka principles attribute drug actions to components like Rasa-Guna-Veerya-Vipaka-Prabhava,
emphasizing holistic effects Chemical isolation may lead to adverse effects, as
drugs contain synergistic fractions that mitigate harm. Ayurveda advocates
whole-drug usage to achieve desired effects without side effects, aligning with
its holistic approach to health. Therefore, treating the individual as a whole
and administering drugs in their entirety reflect Ayurveda’s core principles.
Ayurveda always advocates “Shamanam Nah Tu Kopanamâ€. Let us try to
understand the real essence of the Ayurveda with help of its own basic concepts.
Thus, this clinical trial aims to assess the efficacy of the
entire moola of Makandi in managing Sub Clinical Hypothyroidism,
aligning with Ayurvedic principles. We can get some references of
Hypothyroidism as Kaklaka granthi apachaya, Galaganda, Gandamala , Apachi &
to some extent Agnidushti being the nidan behind it.
Building Confidence on Single drug therapy & Low cost
with High effective therapy is need of the hour. Keeping this in view Single
Drug with effective dosage W.S.R to the drug MAKANDI (Coleus forskohli Briq)
moola churna Capsule is considered for current study. |