The Methodology 

The Aim of the Study of the Study

1.   Normalize the levels of TSH in the fresh cases.

2.   To maintain the TSH levels in the patients who are already using the allopathic drug thyronorm and gradually replacing the allopathic drug with the trail drug

Type of trial: Open trail

Mode of administration: Oral

Method of administration: 

1. For fresh cases started immediately after the diagnosis confirmed.

2. For the patients who are already using thyronorm advised withdraw the 25 mcg of the drug before starting the rail drug.

3. The patients were observed carefully for 1 month, if they are comfortable with the drug and dosage and TSH levels are maintained well they are advised to withdraw another 25mcg. This way the drug is totally replaced with the trail drug.

Dose of the drug:  i) Kanchanara guggulu 250mg b.d.

                                    ii) Shigru patra kwatha 250ml b.d

Period of study: 3 months

Patients were advised not to take Kapha and Medo vardhaka Ahara and Vihara’s like diwaswapna, madhura guru dravya sevana etc.

Clinical Assessment

The progress of the patient is observed and recorded after every 15 days. This procedure is followed for duration of 90 days.  After the completion of the duration the results are assessed basing on observations. The results are assessed in terms of complete relief, marked, moderate and mild relief and no relief.   

1. Complete relief: TSH levels normalized and 100% symptoms relieved.   

2. Marked relief: TSH levels normalized and symptomatic relief up to 75%.  

3. Moderate relief: TSH levels normalized and symptomatic relief up to 50-75%.   

4. Mild relief: TSH levels normalized and symptomatic relief up to 25-50%.   

5. No relief: no change in the TSH levels and no symptomatic relief.

32 patients were recruited in the study and the assessment was done for every 15days.Of the 32 patients 16 patients were fresh cases and 16 patients are already using the modern medicine eltroxin. The results of the patients who completed the treatment of 90days were analyzed.

In the 16 fresh cases the TSH levels came to normal range after the completion of the treatment. The 16 who are already using allopathic medicine were gradually replaced with the trial drug and the TSH levels were in normal range as summarized in table 5.11 and 5.12.

Table 5.11 showing the levels of TSH before and after treatment

For the patients who are already using thyronorm advised withdraw the 25 mcg of the drug before starting the trail drug. The patients were observed carefully for I month, if they are comfortable with the drug and dosage and TSH levels are maintained well they are advised to withdraw another 25mcg and the drug was totally replaced with Trial drug. 

Table 5.12 showing the levels of TSH before and after the treatment in chronic cases.

Many of the symptoms of hypothyroidism are non-specific. The most common symptoms observed in the 32 selected patients, before and after treatment were summarized as shown in below table. 

The most commonly seen symptoms are weight gain or unable to loss weight, menstrual irregularities, vague body pains, constipation, puffiness of the face, hands and feet. The rare symptoms are recurrent attacks of infections, respiratory symptoms etc.

Table 5.13 showing the symptomatic relief percentage:

The over all relief percentage

The TSH levels became normal in the fresh 16 cases, showed a p value of 0.0174, statistically significant. In 2 patients after withdrawl of the drug no recurrence is noted even after 6months. In the chronic cases that are already using the allopathic drug Thyronorm, the drug was gradually replaced with the trail drug. The TSH levels were maintained during the replacement time.

Out of the 32 recruited cases 6 cases shown marked relief. These 6 cases were fresh cases. Moderate relief was observed in chronic cases and in those thyronorm withdrawal cases. 4 cases with long duration showed mild relief. Complete relief and no relief were not observed in the present study.

Table 5.14 showing the result of overall treatment:

Discussion                     

Hypothyroidism doesn’t have any characteristic symptoms. There are no symptoms that people with hypothyroidism always have and many symptoms of hypothyroidism can occur in people with other diseases. Hypothyroidism is sometimes referred to as a "silent" disease because early symptoms may be so mild that no one realizes anything is wrong.

Kanchanara Guggulu⁶ (Sa. Sam), a well-known Ayurvedic drug is selected for this trail to evaluate its efficacy on hypothyroidism. The trail was conducted on 32 patients from the Govt Ayurvedic Hosp, Erragadda; Analysis was made to assess the results in relation to various factors. 

It is a well-known fact that the disease Hypothyroidism is more common in women than men, probably because hormonal imbalance acts as a trigger for thyroid problems. Women’s bodies have a delicate balance of hormones such as estrogen and progesterone, which can be upset when the body is under stress and not receiving enough support. And also estrogens increases the concentration of TBG and of total T₃ and T₄ levels. In the present clinical study also out of 32 patients 30 were female and 2 of them were male.

Hypothyroidism can develop at any point in the life span. It is more common in adults. In this clinical trail age incidence is high in the 2^nd and 3^rd decades, 80% of the cases were found in this age group. It may be because the medical Practitioners and the patients are now more aware of this disease than in the last few decades. 

Actually the women, especially those older than 50, are more likely to have hypothyroidism. But the symptoms of hypothyroidism are often subtle, or people believe their symptoms are due to stress, depression, or "getting older," or may frequently mistake for other conditions; it is not unusual for someone with hypothyroidism to go undiagnosed, sometimes for many years. And also because the symptoms of hypothyroidism and menopause are so similar, hypothyroidism may easily be missed.

 In the recent year’s peculiar changes in the cultural and social areas forcing the human beings to arenas of tremendous stress. It is becoming more prevalent in the modern society and upper socio economic classes. As thyroid gland is one of the sensitive glands in the body it stimulates to stress easily the incidence is high in this group. Whereas iodine deficiency hypothyroidism is associated with lower/poor socio economic classes due to poor nutrition.

The disease is seen more in 1. Kapha prakriti predominants, 2.Mamsa, Medo sara predominants, 3. predominantly Non- vegetarians; 4. Those who consume more saturated fatty diet, 5. Whose BMI is above 20.

These all come under one umbrella "the sedentary life style".

Heredity plays a role in both under active and overactive thyroid; Recent studies show that 20% of the diabetic daughters area at the risk of developing thyroid disorders. In the present trail 50% of the patients had a family history of autoimmune disorders like DM, hypothyroidism, psoriasis etc.,

People with many autoimmune diseases have a higher risk for hypothyroidism. One patient suffered from Rheumatoid Arthritis and Diabetes Mellitus. Another patient was ASMA +ve  (Anti Smooth Muscle Antibodies) with chronic autoimmune hepatitis and Hasimoto’s Thyroiditis and Vitiligo. Another was a case associated with Hyper Parathyroidism and Osteoporosis, Ca supplement was added along with the trail drug. 

Another case a 25 yr female c/o unable to attain menarche with hypothyroidism diagnosed as turners syndrome with streak ovaries, she was counseled properly as turners syndrome is highly impossible to treat and was given treatment for hypothyroidism only.  

Numerous medications can affect the thyroid. Some drugs given for non-thyroid conditions have the side effect of inhibiting production of thyroid hormone within the thyroid gland. If these drugs are taken in large dosages or for a long time, hypothyroidism may result. Nitroprusside, lithium, or iodides in the form of cough syrups, steroid and beta-blocker proponolol etc, and can induce hypothyroidism.

Among the 32 patients 2 patients had a history of using steroids and 3 patients had a history of using medications for depression and insomnia, 2 patients had a history of using immuno-suppressants. 6 patients had a history of hysterectomy. It may be because hypothyroidism, in the early stages presents with Menorrhagia, which may be easily misdiagnosed.

Another was a case of Juvenile Hypothyroidism, a 13 yr old boy with a BMI of more than 38 (wt 78kilos) with typical dull expressionless face, myxedamatous, thick, rough, cold doughy skin, hypercholestremia and delayed DTR’s, deep slow voice and other symptoms. Unfortunately the case was a drop out.

The TSH levels became normal in the fresh 16 cases, in 2 patients after with drawl of the drug no recurrence is noted even after 6months. In the chronic cases that are already using the allopathic drug Thyronorm the drug was gradually replaced with the trail drug. The TSH levels were maintained during the replacement time. 4 patients were advised to continue the medication along with the allopathic drug, as they are at the perimenopausal stages, and the chronicity of the disease is high.

Coming to the results, 33% of relief was observed in those who complained of weight gain or unable to loss weight. Good results were observed in the fresh cases and who exercised regularly. But in the chronic cases that were habituated to sedentary life style no significant results were observed. In the patients who got relief there was 4/5 kilo of weight loss was observed in the three months duration. Exercise is especially important for weight loss among hypothyroidism sufferers.

Menstrual irregularities are the main symptom in hypothyroid patients, which brings them to the hospital. In among the 32 patients 50% of the patients complained of menstrual irregularities, most of them also complained of oligomenorrhoea. 87.5% relief was observed in these cases. In 2 patients who complained of infertility one had altered FSH levels and Anovulatory cycles, another patient complained of repeated abortions. In both of these patients infertility was not relieved in 3 months durations of the course.

Another main symptom constipation, poor appetite, gaseous distention was 95% relieved after the treatment, as the all the ingredients in the trail drug acts as Deepana and Pachana.

Vertigo, mood disturbances, easy fatigability, tiredness, lethargy, slowness of memory, intellect and thought were the early symptoms and marked relief was observed in these symptoms.

Parasthesia’s, muscle cramps, weakness, muscles stiffness and aching were the main complaints of the chronic cases. 50-60% of relief was observed in these cases, as Guggulu acts as anti-inflammatory and analgesic.

15 patients complained of occasional voice changes like hoarseness; slowness of voice etc. 66% relief was noted. Hair loss was seen in 18 patients and 60% of relief was observed in these cases. Dry, rough skin is seen in 70% cases and half of the patients got relief.  35% of cases showed dry, brittle, lusterless hair. Brittle nails, recurrent attacks of infections were observed in many patients. 85% of the cases showed significant improvement in puffiness of the face, feet and palms.

One patient’s only complaint was chronic rhinitis.

Cardiac and respiratory symptoms are rarely observed in 32 patients. One patient, aged 65yrs with Bradycardia, Cardiomegaly was seen. But it was under exclusion criteria. 

Goiter was seen in 11 cases, the trail drug showed effective in acute and grade I Goiter. No significant results were observed in chronic cases. In one case of euthyroid and MNG (multi nodular goiter) since 6yrs, the recent nodule noted 3months back was reduced and other nodules become soft in consistency in the duration of 3 months.  

Thinning of the lateral thirds of the eyebrows (Queen Anne’s sign) was noticed in one patient.

Complications

During the replacement of the allopathic drug, puffiness of the face, mood disturbances, feeling of heaviness, muscle cramps were noted in 4 patients. But it was adjusted by increasing the dosage of the trial drug.

Gastritis was another complaint seen in 2 patients, but it was negligible and was controlled after minimizing the dosage of Kanchanara Guggulu.

Conclusion

1. The trail drug Kanchanara Guggulu and Shigru Patra Kwatha is found to be beneficial in recently diagnosed cases.

2. Mild to moderate relief was noted in patients who are already using the drug thyronorm and it can be completely replaceable with the trail drug depending upon the rogi bala and rogibala. TSH levels and the clinical features should be carefully monitored.

3. The patients who are in perimenopausal or menopausal stages, who has a chronicity of more than 10yrs, who has a history of autoimmune disorders it would be advisable to continue the medication along with the thyronorm.

References

1. Human physiology by CC Chuttarjee. Medical allied Agency, Calcutta, 1988.

2. Applied physiology by Best and Taylor.

3. Robbins textbook of pathology, Robbin.

4. Human Endocrinolgy by Paul R Guard, Taylor and Francis, 1988.

5. Endocrinology by Andrew lewy, Stafford lightman, Oxford University Press, 1997.

6. Sarangadhara Samhita

7. Nighntu Adarsh, Bapalal G Vaidya, Choukambha Sanskrit Series, Varanasi.

8. Dravyaguna Vignanam By K Nisteswar, AP Literature Improvement Trust.

9. Dravyaguna Vignan by JLN Sastry, Chaukhambha Sanskrit series.

10. Charaka samhita

11. Sushruta samhita

12. Bhela samhita

13. Kashyapa samhita

14. Diagnostic tests in Endocrinology and Diabetis, Ed by P Boulax and LH Books.

15. Essential endocrinology by Oxford University Press, 1966.

16. Endocrine Patho Physiology, Hershman, JM Lea and Fibriger, 1998.

17. Essential endocrinology Charles Brooks, Nicholas Marshal, Blackwell series, 3^rd Ed.

18.  Thesis: (Clinical study on the effect of kanchanara guggulu and shigru patra kwath on hypothyroidism by Dr. V.Vijaya lakshmi prasuna, PG scholar; Dept of kaya chikitsa under the guidance of Dr. Prakash chander; Professor and HOD; Dept of kaya chikitsa, Dr. BRKR Govt ayurvedic college, Hyderabad.)

June 21, 2008

Disclaimer
The above article is educational and informative in nature, and is not intended to diagnose, treat, cure or prevent any disease. If you have a medical condition, please consult your physician. 

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