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SHORT COMMUNICATION
Year : 2018  |  Volume : 39  |  Issue : 1  |  Page : 50-55  

A clinical study to evaluate the role of Triphaladya Guggulu along with Punarnavadi Kashaya in the management of hypothyroidism


Department of Panchakarma, Institute for Postgraduate Teaching and Research in Ayurveda, Jamnagar, Gujarat, India

Date of Web Publication3-Dec-2018

Correspondence Address:
Dr. Karishma Singh
Department of Panchakarma, Institute for Postgraduate Teaching and Research in Ayurveda, Jamnagar, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.AYU_62_17

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   Abstract 


Context: Hypothyroidism is one of the most common thyroid disorders in India, affecting one in ten adults. Although the diagnosis and treatment of hypothyroidism are often considered simple, there are large number of people with this condition who are suboptimally treated. Due to wide spectrum of the disease and high prevalence in the society, the current issue was opted for study and its management by means of Ayurvedic principles. Materials and Methods: Fifteen eligible hypothyroid patients with serum thyroid-stimulating hormone >4.5 μIU/ml and serum T3and T4 lower than their respective normal range were selected and treated with Triphladya Guggulu pills and Punarnavadi Kashayam (decoction) for 45 days. Patients were advised to discontinue any medicine they might be taking for the management of hypothyroidism to assess the unbiased effect of therapies. Results: Significant improvement was observed on subjective parameters, but the results on objective parameters were statistically insignificant (P > 0.05). Of the 15 enrolled patients, excellent improvement was observed in 33.33% of the patients, while marked improvement was reported by 53.33% of the patients, moderate improvement was found in 6.66% of the patients and same number of patients, that is, 6.66% showed mild improvement. Moreover, few interesting observations were noted 4 months after completion of the trial. Out of 15 patients registered, 86.66% had positive drug history for levothyroxine. After clinical trial, 6.66% of the patients continued their previous dosage of levothyroxine, while 80% of the patients had withdrawn their hormone replacement therapy. Conclusion: Triphladya Guggulu and Punarnavadi decoction are effective in the management of hypothyroidism.

Keywords: Hypothyroidism, Punarnavadi decoction, Triphladya Guggulu


How to cite this article:
Singh K, Thakar AB. A clinical study to evaluate the role of Triphaladya Guggulu along with Punarnavadi Kashaya in the management of hypothyroidism. AYU 2018;39:50-5

How to cite this URL:
Singh K, Thakar AB. A clinical study to evaluate the role of Triphaladya Guggulu along with Punarnavadi Kashaya in the management of hypothyroidism. AYU [serial online] 2018 [cited 2018 Dec 18];39:50-5. Available from: http://www.ayujournal.org/text.asp?2018/39/1/50/246790




   Introduction Top


The incidence of thyroid disorders in India is high, with hypothyroidism being a condition that is not adequately controlled in the country at present. Lack of thyroid hormone or resistance of the body tissue to thyroid hormone with respect to metabolic demand results in disorder called hypothyroidism. Thyroid hormone is required for the normal functioning of each and every tissue of the body. Hence, its deficiency manifests as multisystem involvement. It is estimated that about 42 million people suffer from thyroid disorders in India, of which hypothyroidism is most common with a prevalence of 5.4%.[1] The modern system of medicine is still exploring medicine for better and more effective management of hypothyroidism. Synthetic thyroid hormone derivatives may bring the value of thyroid-stimulating hormone (TSH) and T4 to normal range, but the increased dosage and continuous medicine make the patient drug dependent till the end of the life. Even after years of treatment, it is associated with failure to provide relief in clinical manifestations. Moreover, excessive thyroid hormone replacement carries the potential for serious long-term metabolic complications (e.g., accelerated osteoporosis).[2]

The major function of the thyroid gland is to act as a spark for the maintenance of oxidative metabolism in most tissues. In Ayurveda parlance, this is attributed as the function of Agni (system related to metabolism). As far as the management of hypothyroidism through Ayurveda is concerned, hormonal replacement is not possible through drugs. However, one can interpret the pathogenesis of hypothyroidism in the context of Ayurveda, in which role of Agni is foremost and through its management, wholesome normal activity of the thyroid gland may be achieved. The objective of treatment should be to address the problem at its root by regulating the immune system and decreasing inflammation. Srotoshodhana (cleansing of the macro and microchannels), Agnideepana (stimulation of the digestion and metabolism), Pachana (digestion) and Vatanulomana (proper regulation of excretory system) are the main principles of treatment.

The trial drug Punarnavadi Kashayam[3] is mentioned in Chakradatta for the management of Shotha (odema), which is one of the common manifestations of hypothyroidism. It contains Punarnava, Devadaru and Shunthi along with Guggulu. Triphladya Guggulu[4] is cited in Yogaratnakara for the management of Gandamala. It contains Guggulu in combination with Trikatu, Triphala and Kanchanara. The drug possesses Deepana-Pachana Dravya along with Kanchanara, which is widely being practiced for the management of hypothyroidism. Thus, keeping in mind the possible effects of trial drugs in normalizing the impaired Agni, they were selected to evaluate their efficacy in the management of hypothyroidism.


   Materials and Methods Top


Selection of patients

A total of 15 patients suffering from hypothyroidism were selected from outdoor patient department and indoor patient department of Panchakarma, IPGT & RA, Jamnagar, irrespective of their sex, religion, caste, occupation etc.

Ethical clearance was obtained from the Institutional ethics committee vide PGT/7-A/Ethics/2015-2016/1490/2.42 dated August 25, 2015. This study is registered in Clinical Trial Registry of India with registration no. CTRI/2016/10/007378. Informed written consent in language suitable to the patients was obtained from all enrolled participants.

Inclusion criteria

  • Diagnosed cases of hypothyroidism on the basis of serum TSH, T3 and T4 levels.


    • Patient's serum TSH level >4.5 μIU/ml[5]
    • Total serum T4 level less than normal value (total serum T4= 4.5–12.5 μg/dl)
    • Total serum T3 level less than normal value (total serum T3= 80–220 ng/dl).


  • Patients having clinical features of hypothyroidism:


    • Puffiness of the face and eyelids
    • Peripheral edema
    • Dry coarse skin
    • Breathlessness
    • Constipation
    • Weakness
    • Lethargy
    • Fatigue
    • Muscle ache
    • Menstrual abnormality
    • Hair loss
    • Age 20–60 years.


Exclusion criteria

Patients with ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular event, cardiac arrhythmias, pregnancy and active malignant disease were excluded from the study.

Laboratory investigations

  • Routine hematological (complete blood count and erythrocyte sedimentation rate) investigation.
  • Thyroid profile (serum T3, serum T4, serum TSH)
  • Lipid profile (serum cholesterol, serum triglyceride, serum low-density lipoproteins, serum very LDL, serum high-density lipoprotein). These investigations were carried out before and after the treatment.


Methodology

All the patients were advised to discontinue any drug they might be taking for the management of hypothyroidism to assess the unbiased effect of therapies. The drug was withdrawn 1 week before including the patient in the clinical trial.

All the patients were advised to take meal only upon hungry, green gram predominant diet, to avoid full stomach diet and to refrain from dairy products or heavy to digest food articles. Patients were strictly advised to abstinate from day sleep during the trial period.

Drugs and dosage

  • Triphladya Guggulu 2 Vati twice daily (each Vati weighing 500 mg) with lukewarm water after meal
  • Punarnavadi decoction 30 ml twice a day before meal.


The trial drugs were procured from Pharmacy, Gujarat Ayurved University. Ingredients of the same are mentioned in [Table 1] and [Table 2].
Table 1: Ingredients of Triphaladya Guggulu

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Table 2: Ingredients of Punarnavadi Kashaya

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Preparation method of trial drugs

Triphladya Guggulu

T. Guggulu was prepared by dissolving Triphala purified Guggulu in Kanchanara bark decoction until it attained a sticky consistency, followed by addition of powders of Trikatu and Triphala along with quantity sufficient honey for making pills of 500 mg size.

Preparation of Punarnavadi Kashayam

Patients were advised to boil 15 g of coarse powder of Punarnavadi Yavakuta in eight parts of water and reduce it to one-fourth over mild heat and to consume it empty stomach twice daily.

The trial drugs were administered for 45 days.

Follow-up study

After completion of the therapy, patients were followed for 1 month.

Criteria for assessment

  1. Improvement observed in patients was assessed mainly on the basis of relief in percentage change in the presenting complaints of hypothyroidism on the basis of scoring pattern decided in a previous study [Table 3][5]
  2. Thyroid profile (Serum TSH, T3 and T4).
Table 3: a-l: Grading criteria

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Statistical analysis

The data obtained in the study were subjected to statistical analysis to evaluate the significance of curative effect of therapies.

Subjective criteria

Percentage of improvement in each parameter was calculated. Wilcoxon's signed-rank test was applied to the data to analyze the effect of therapy on subjective parameters.

Objective criteria

Obtained data of objective parameters were subjected to student's paired t-test to analyze the effect of therapy on objective parameters.

The results were interpreted at P < 0.05, P < 0.01 and P < 0.001 significance levels.

Observations

Out of the 15 registered patients, maximum patients belonged to age group of 31–40 years (60%) and majority of the participants were female (93.34%). History of hypertension was reported in 93.34% of the patients. Family history of hypothyroidism was positive in 40% of the patients. Chronicity more than 5 years was reported in 40% of the patients. Samashana (taking wholesome and unwholesome food together) and Adhyashana (eating in spite of indigestion) were practiced by 80% and 53.34% of the patients, respectively. Lavana Rasa (salty), Madhura Rasa (sweet), Katu Rasa (pungent taste) and Amla Rasa (sour) predominant diet were reported being consumed by 100%, 93.34%, 93.34% and 66.67% of the patients, respectively. Nearly 100% of the patients had the habit of holding their natural urges (Vegasandharana). About 86.67% of the patients reported Avyayama (lack of exercise). Divaswapna (day sleep) was practiced by 73.34% of the patients. Atichintana (over worry) was found in 73.34% of the patients. Mandagni (weak digestive system) was observed in 60% of the patients. About 66.67% of the patients had Krura Koshtha (costive bowel). Symptoms of vitiation of Rasavaha and Medovaha Srotasa were observed in 100% of the patients followed by Annavaha Srotodushti in 93.33% of the cases.


   Results Top


Effect of therapy on presenting complaints of hypothyroidism

The results were significant in almost all the signs and symptoms of hypothyroidism. Highly significant improvement (P < 0.001) was observed in weakness, fatigue and muscle ache and the results were statistically significant (P < 0.01) on all the other complaints such as puffiness over the face and eyelids, peripheral edema and dry coarse skin [Table 4].
Table 4: Effect of therapy on chief complaints using Wilcoxon's signed-rank test

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Effect of therapy on weight and body mass index

There was a significant decrease (P < 0.01) in weight and body mass index by 3.14% and 3.20%, respectively [Table 5].
Table 5: Effect of therapy on weight and body mass index

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Effect of therapy on thyroid profile

Serum TSH was insignificantly elevated (P > 0.05) by 40.66%, serum T3 was insignificantly decreased (P > 0.05) by 6.78%, and an increase of 7.95% in serum T4 was observed which was statistically insignificant [Table 6].
Table 6: Effect of therapy on thyroid profile

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Effect of therapy on hematological parameters and lipid profile

There was statistically insignificant change (P > 0.05) in all the hematological parameters and lipid profile.

Overall effect of therapy

Excellent improvement was found in 33.33% of the patients 53.33% of the patients showed marked improvement, 6.66% of the patients showed moderate improvement and same percentage that is 6.66% of the patients showed mild improvement. None of the patients remained unchanged [Table 7].
Table 7: Overall effect of therapy

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   Discussion Top


In most cases of hypothyroidism, a specific cause is not apparent. It is believed that hypothyroidism is usually secondary to an autoimmune reaction.[6] In autoimmune disorders, the immune system cells do not recognize the cell as “self” and mount an immune response against them. This self-attack by the immune system increases inflammation and inflammation has a profound effect on all aspects of thyroid metabolism and physiology. Pro-inflammatory cytokines can inhibit type 2 5'-deiodinase enzyme activity which is required for the conversion of T4 to T3.[7] Inflammation causes elevated cortisol levels, leading to a decrease in TSH and lowered thyroid hormone production. Cortisol also inhibits the conversion of T4 to active T3 and increases the conversion of T4 to reverse T3.[8] Thyroid hormones stimulate diverse metabolic activities in most tissues, leading to an increase in basal metabolic rate. By way of analogy, the action of thyroid hormones is akin to Agni. The cause of disease, that is, impaired metabolism can be compared with Agnimandya.

Discussion on effect of therapy on thyroid profile

Out of 15 patients in the present trial, 10 patients had encouraging results in thyroid profile, not much change in thyroid profile was observed in 2 patients but the result worsened in 3 patients. On retrospective analysis, it was observed that patients whose thyroid profile had worsened during the trial had Vata-Kapha Prakriti, which can make the disease condition difficult to treat, due to the Vata-Kapha predominance in disease. Chronicity in those cases was reported to be more than 5 years. All of them had positive history for intake of levothyroxine. Chronicity and past treatment history can also be considered as one of the factors for negative results. Stress was a common factor in all these patients. One of these patients was a case of hypothyroidism caused after the treatment for Grave's disease and in patients who develop hypothyroidism after the treatment of Graves' disease, there is often an underlying autonomous function, necessitating lower replacement dose. This might be the reason why thyroid function worsened in this patient. The half-life elimination of thyroxine (T4) in hypothyroid patients is 9–10 days.[9] Half-life (abbreviated t½) is the time required for a quantity to reduce to half its initial value, but the washout period in the present trial was 7 days, this reflects that before treatment thyroid profile was under the influence of levothyroxine, whereas after treatment, the change in thyroid profile was solely under the influence of trial interventions.

Recovery of the hypothalamic–pituitary axis usually requires 8 weeks at which time the TSH and free T4 levels can be measured,[10] that is, TSH responses are gradual and should be measured about 2 months after instituting treatment.[11] However, the duration of the trial was limited to 6 weeks. Despite the short duration of the clinical trial, positive changes were observed in thyroid profile in 10 of 15 patients.

Thus, from the above observations, it can be inferred that both the trial drugs were helpful in normalizing the thyroid function, but better results could have been possible if the duration of trial was longer.

Mode of action of trial drugs

In hypothyroidism, etiological factors mainly vitiate Tridosha (Kapha predominance associated Pitta vitiation and Margavaranajanya [hindrance of function] leading to provoking of Vata). This Tridosha vitiation invites derangement of Jatharagni (digestive system), ultimately leading to the derangement of Dhatvagni (metabolic system) and subsequent appearance of Ama. This Ama blocks the channels in the body (Srotorodha), thereby afflicting the contents of channels causing vitiation of Srotasa as well as Dhatu to which these Srotas deliver.

The trial drug Triphaladya Guggulu is cited in Yogaratnakara Gandamala Chikitsa consists of Guggulu in combination with Trikatu, Triphala and Kanchanara. Punarnava Guggulu possesses digestive property to normalize excretory function, scraping of vitiated Meda with non-desirable Dhatu and Vata-Kapha pacification properties. Trikatu is known to have digestive and Vata-Kapha pacification properties. Digestive drugs prevent the formation of Ama, thereby preventing damage by keeping balanced state of digestion and metabolism. Triphala has Tridosha pacification properties and supports healthy digestion and absorption.

Punarnavadi decoction mentioned in Chakradatta Shotha Chikitsa contains Punarnava, Devadaru and Shunthi along with Guggulu as an adjuvents. The roots of Punarnava are claimed to possess diuretic and laxative[12] properties and thus might have been functional in alleviating swelling, the most common presenting complaint. Devadaru possesses anti-inflammatory, immune-modulatory and diuretic properties.[13] Vitamin C is an active component of Devadaru.[13] Studies have shown that natural antioxidant therapy such as Vitamin C can reverse thyroid damage and prevent adverse effects to health by optimizing thyroid function.[14] Moreover, Devadaru has Lekhana action. These properties of Devadaru might have helped in reducing weight.[13] Shunthi owns digestive, pain-alleviating and Vata-Kapha pacification properties, preventing the formation of Ama. Preventing the formation of Ama can correct the pathogenesis at the beginning itself.

Few observations noted after the trial

Out of 15 registered patients, 86.66% had positive drug history for consumption of levothyroxine. After clinical trial, 6.66% of the patients continued their previous dosage of levothyroxine, while 80% of the patients had withdrawn their hormone replacement therapy. Not all the 80% of the patients who had withdrawn levothyroxine could restore normal thyroid profile, but they were quite satisfied with Ayurvedic management and were not willing to resume previously on-going synthetic thyroxin. These observations were noted 4 months after the completion of the clinical trial. An additional observation was that on long-term follow-up, thyroid profile showed a trend toward normalcy even in the cases that could not restore normal thyroid profile during the trial.


   Conclusion Top


Although any disease condition is not described in Ayurveda which is similar to hypothyroidism, it is found to possess a strong correlation with Agnimandya and Ama. The trial drugs showed highly significant results on subjective parameters. Vitiation of Dhatvagni once created cannot be corrected easily; hence, Shamana therapy should be administered for sufficient time to cure Ama at Dhatu level. From the clinical trial, it can be concluded that Triphaladya Guggulu and Punarnavadi decoction are effective in the management of hypothyroidism.

Financial support and sponsorship

The study was financed by IPGT and RA, Gujarat Ayurved University, Jamnagar.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Available from: http://www.japi.org/thyroid_special_jan_issue_2011/article_01.html. [Last cited on 2017 Apr 21].  Back to cited text no. 1
    
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Nuovo J, Ellsworth A, Christensen DB, Reynolds R. Excessive Thyroid Hormone Replacement Therapy. Available from: http://www.jabfm.org/content/8/6/435.full.pdf. [Last cited on 2017 Apr 22].  Back to cited text no. 2
    
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Shastri LP. Yogratnakara. Gandamala-apchi chikitsa. In: Triphladya Guggulu. Vol. 1-2. Varanasi: Chaukhamba Prakashan; 2013. p. 150.  Back to cited text no. 4
    
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Ranjan M, Thakar A. A Comparative Clinical Study of Vamana and Virechana Karma Along with Shamana Therapy in the Management of Hypothyroidism. IPGT and RA. Jamnagar: Department of Panchakarma, Thesis Submitted to Gujarat Ayurved University; 2016.  Back to cited text no. 5
    
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Fritz MA, Speroff L. Reproduction and the thyroid. Clinical Gynaecological endocrinology and infertility. In: Clinical Endocrinology. South East edition. 8th ed. Sec. 2, Ch. 20. New Delhi: Wolters Kluwer (India) Pvt Ltd.; 2011. p. 889.  Back to cited text no. 6
    
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Osansky E. 6 Factors Which Can Affect The Conversion of T4 to T3. Available from: http://www.naturalendocrinesolutions.com/archives/6-factors-which-can-affect-the-conversion-of-t4-to-t3/. [Last cited on 2018 Jul 12].  Back to cited text no. 7
    
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Lisandro Irizarry, Nadine A Youssef, Anton A Wray. Thyroid Hormone Toxicity; 2016. Available from: https://emedicine.medscape.com/article/819692-overview#a5. [Last cited on 2018 Jul 24].  Back to cited text no. 9
    
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Fritz MA, Speroff L. Reproduction and the thyroid. Clinical Gynaecological endocrinology and infertility. In: Clinical Endocrinology. South East edition. 8th ed, Sec. 2, Ch. 20. New Delhi: Wolters Kluwer (India) Pvt Ltd.; 2011. p. 892.  Back to cited text no. 10
    
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Fauci AS, Hauser SL, Kasper DL, Longo DL, Jameson JL, Loscalzo J. Disorders of the thyroid gland. In: Harrisons Principle of Internal Medicine. 18th ed, Vol. 2, Ch. 341, Part 16. United States of America: The McGraw-Hill companies; 2011. p. 2921.  Back to cited text no. 11
    
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Mahesh AR, Kumar H, Ranganath MK, Devkar RA. Detail study on Boerrhavia diffusa plant for its medicinal importance-a review. Res J Pharm Sci 2012;1;28-36.  Back to cited text no. 12
    
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The Central Council of Research in Ayurveda and Siddha. Database on Medicinal Plants Used in Ayurveda. Vol. 7. New Delhi: The Central Council of Research in Ayurveda and Siddha; 2005. p. 72.  Back to cited text no. 13
    
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Vitamin C Deficiency Wreaks Havoc on Thyroid Function. Available from: http://www.naturalhealth365.com/thyroid-function-adrenal-fatigue-vitamin-c-1516.html. [Last cited on 2017 Apr 22].  Back to cited text no. 14
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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