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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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 Whole”, 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 Kopanam”. 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.

 
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