A clinical research trial to find the safety and effectiveness of asgand and brahmi in underactive thyroid gland function
- Conditions
- Hypothyroidism, unspecified,
- Registration Number
- CTRI/2020/04/024655
- Lead Sponsor
- National Research Institute of Unani Medicine for Skin Disorders Hyderabad
- Brief Summary
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|Need for the Study
Primary hypothyroidism refers to hormone deficiency caused by intrinsic thyroid gland dysfunction that disrupts the synthesis and secretion of T4 and T3. Primary hypothyroidism is one of the most common endocrine conditions, occurring in 5% of individuals. Mild hypothyroidism is present in as many as 15% of older adults. Hypothyroidism is more common in women.
Hypothyroidism continues to grow significantly in the country particularly among women. A survey conducted by Indian Thyroid Society depicts one in ten adults in India suffer from hypothyroidism. According to survey, the disease is more prevalent among women who are three times more likely to be affected by hypothyroidism than men especially in the age group of 46-54 years. A significant proportion of patient population may go undetected and untreated even as it continues to impair the daily quality of life, work performance and economic productivity [14].
Thyroid hormone deficiency affects almost all body functions; and hypothyroidism if left untreated, may lead to complications such as infertility, delirium, dementia, cerebellar ataxia, seizures, psychosis (myxedema madness), confusion, myxedema coma, hypothermia, severe cardiac failure (myxedema heart), pericardial effusions, etc.
In conventional medicine, levothyroxine is being used effectively in the management of hypothyroidism, but it can suppress the TSH to subnormal range and can cause serious side effects on bone density and cardiac function, such as osteoporosis, atrial fibrillation, myocardial ischaemia, etc. Therefore, there is a need to develop safe and effective drug for the management of *Qillat-e-Darqiyyat* *Aá¹£li* (Primary Hypothyroidism).
In a recent survey conducted by American Thyroid Association demonstrated that patients taking natural preparations, rather than synthetic hormone replacement therapy or combination therapy, were more satisfied with their treatment [20]. Asgand (*Withania somnifera*) and Brahmi (*Bacopa monnieri*) have been used for centuries in Unani system of medicine for various ailments; and a combination of *Asgand* and *Brahmi* is being used for the management of depression, anxiety and chronic stress[22]; none of the studies have evaluated the effect of this drug combination in hypothyroidism. However, it has been shown in most of the pharmacological studies that both the drugs can stimulate the thyroid gland to produce more T4 hormone [15-17,19,23,24].
Keeping these facts in mind, it has been decided to conduct a research work entitled “A Randomized, Active-Controlled, Assessor-Blinded, Parallel Group Clinical Study to evaluate the safety and efficacy of *Asgand* and *Brahmi* in the Management of *Qillat-e-Darqiyyat* *Aá¹£li* (Primary Hypothyroidism)â€.
|Review of Literature
The thyroid gland is a butterfly-shaped endocrine gland that is located in the lower front of the neck. The thyroid’s job is to make thyroid hormones, which are secreted into the blood and then carried to every tissue in the body. Thyroid hormone helps the body use energy, stay warm and keep the brain, heart, muscles, and other organs working as they should. Hypothyroidism is an underactive thyroid gland [1]. Hypothyroidism means that the thyroid gland can’t make enough thyroid hormone to keep the body running normally. When thyroid hormone levels are too low, the body’s cells can’t get enough thyroid hormone and the body’s processes start slowing down and shows the symptoms like tiredness, weakness, dry skin, feeling cold, hair loss, difficulty concentrating, poor memory, constipation, weight gain with poor appetite, dyspnoea, hoarse voice, menorrhagia (later oligomenorrhoea or amenorrhoea), paraesthesia, impaired hearing; and signs like dry coarse skin, cool peripheral extremities, puffy face, hands, and feet (myxoedema), diffuse alopecia, bradycardia, peripheral edema, delayed tendon reflex relaxation, Carpal Tunnel Syndrome, and serous cavity effusions [2].
As such hypothyroidism has not been described in Unani classical literature, but some of the clinical features associated with this disease are very much similar to those described in the context of *Su’-i-MizÄj BÄrid* (abnormal cold temperament). According to Unani literature, the normal temperament of the thyroid gland is hot [3], but in hypothyroidism it changes from hot to abnormal cold temperament (*Su’-i-MizÄj BÄrid*). Some Unani scholars consider hypothyroidism as *BalghmaÄ«* (Phlegmatic) disease. *Ghlaba-i-Balgham* (domination of phlegmatic humour) is characterized by bradycardia, low volume pulse, sluggishness of skeletal muscles, puffiness, peripheral edema, cool peripheral extremities, sluggish thinking. These signs and symptoms are found in patients with hypothyroidism [4]. The signs and symptoms of *Su’-i-MizÄj BÄrid* (abnormal cold temperament) include *Khushk wa KhurdarÄ« Jild* (dry and coarse skin), *Shuḥūb* (skin pallor), *LisÄn SamÄ«k* (thick tongue), *Fará¹ al-Nawm* (excessive sleep), *TakÄn* *wa* *Kasalmandi* (lethargy and somnolence), *Nabá¸* *Baá¹Ä«* *wa* *MutafÄwit* (low volume pulse), *KhafaqÄn* (palpitation), *Tahabbuj* (puffiness of face), *Kund Zahni* (diminished intellectual functions), *Ḍu‘f al-Shahwa* (loss of libido), *Ḥuá¹£r* (constipation), *Ḍu‘f al-IshtiḥÄ’* (decreased appetite), [5-9,18,21] etc; and these features coincides with the clinical manifestations of *Qillat-e-Darqiyyat* (hypothyroidism). Thus, *Su’-i-MizÄj BÄrid* including *Su’-i-MizÄj BalghmaÄ«* may beinterpreted with the clinical presentations of *Qillat-e-Darqiyyat* (hypothyroidism). Although the ancient Unani physicians have described a common disorder of thyroid gland in their literature as goiter (enlargement of thyroid gland) and its treatment.
BuqrÄt (Hippocrates) (460-337 BC) narrated in context to the glands that “when glands of the neck become diseased themselves, they become tubercular and produce strumaâ€. The term “struma†is still used in some European countries (e.g. Austria, Italy) as the medical designation of goiter.
IsmÄ‘il JurjÄnī’s ’Treasure of Medicine’ first associated with exophthalmos (protrusion of the eyes), we now associate it with Grave’s disease (goiter). ‘AlÄ« ibn ‘AbbÄs MajÅ«sÄ« (d. 994 AD) stated that the *Waram* which occurs due to *Balgham-e-GhalÄ«z* results in Ghayngha (goiter) which are similar to glands. Ibn Hubal BaghdÄdÄ« (1121-1213 AD) mentioned exophthalmic goiter under the heading *Juḥūẓ al-‘Ayn* (exophthalmos) in his book, “*KitÄb al-MukhtÄrÄt fi’l Ṭibb*â€. He narrated as: “The main cause of *Juḥūẓ al-‘Ayn* is accumulation of matter. The matter may be liquid or gaseous in nature. These matters accumulate in the vessels of the eyes result in dilatation of the vessels. Collectively we can say that increased pressure of vessels of eyes is the cause of diseaseâ€.
According to Ibn SÄ«nÄ (Avicenna), the signs of phlegm being predominant are excessive pallor, flabbiness of body, cold and moist skin, excessive salivation and viscid saliva. Thirst is diminished especially in elderly persons except of course when the acid phlegm predominates. A weak digestion with acid eructation, pale urine, excessive sleepiness, flabby muscles, mental dullness and a soft pulse of slow rate and speed are characteristics of this condition. According to this, the line of treatment when a temperamental abnormality is simple, i.e., without any complicating factor, its treatment is counteraction [7].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 45
Patients of any gender Patients in the age group between 19 and 60 years Patients with Symptomatic Subclinical Primary Hypothyroidism Patients with Clinical Primary Hypothyroidism TSH ranging 5-10mg/dl.
Patients aged <19years or >60 years Asymptomatic cases of Subclinical Primary Hypothyroidism Severe/ complicated cases of Clinical Primary Hypothyroidism Patients with Drug-induced Hypothyroidism Patients on radiotherapy for head and neck region ï‚· Patients who have undergone thyroidectomy ï‚· Pregnant or Lactating Women ï‚· Significant Pulmonary/ Cardiovascular/ Hepatic/ Renal Diseases ï‚· Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies ï‚· Patients with Diabetes Mellitus ï‚· Patients with history of hypersensitivity to Asgand or Brahmi ï‚· Patient not willing to attend treatment schedule regularly.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical assessment will be done at 0, 2, 4 ,6 and 8 weeks and the response to treatment will be assessed using the following parameters: 2nd week | 4th week | 6th week | 8th week 1.Decrease in serum TSH level 2nd week | 4th week | 6th week | 8th week 2.Increase in serum Free T4 level 2nd week | 4th week | 6th week | 8th week 3.Improvement in the symptoms & signs of hypothyroidism as assessed by reduction in Zulewski’s clinical score after treatment 2nd week | 4th week | 6th week | 8th week
- Secondary Outcome Measures
Name Time Method Lab investigation 0 and 8 weeks
Trial Locations
- Locations (1)
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad
🇮🇳Hyderabad, TELANGANA, India
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad🇮🇳Hyderabad, TELANGANA, Indiajuveria jabeenPrincipal investigator8978812833juveriaanam@gmail.com