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 Table of Contents  
CASE REPORT
Year : 2022  |  Volume : 5  |  Issue : 1  |  Page : 35-40

Case report on treatment of Karuppai Naarthasai Kattigal (uterine fibroids) with Rasagandhi Mezhugu


1 Department of Clinical Research, Siddha Regional Research Institute (CCRS), Poojapura, Thiruvananthapuram, Kerala, India
2 Department of Clinical Research, Siddha Regional Research Institute (CCRS), Puducherry, India

Date of Submission24-Jul-2022
Date of Decision03-Dec-2022
Date of Acceptance14-Mar-2023
Date of Web Publication18-Apr-2023

Correspondence Address:
Dr. Annie Jasmine Swapna
Siddha Regional Research Institute, Poojapura, Thiruvananthapuram - 695 012, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jrsm.jrsm_18_22

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  Abstract 

Karuppai Naarthasai Kattigal (uterine fibroids) are benign tumors arising from the smooth muscles of the uterus. This study focuses over a case report of a patient with Karuppai Naarthasai Kattigal (uterine fibroids) treated with a classical Siddha drug, Rasagandhi Mezhugu (RGM) from the literature reference Pulippani Vaithiyam-500, for a period of 90 days, after receiving the informed consent, and the outcome was documented. A 40-year-old woman with a heavy menstrual bleeding, frequent urination, abdominal cramps, and bloating of abdomen often for 6 months and intermenstrual bleeding for 2 years was screened through an ultrasonogram, suspecting uterine fibroids. After Siddha clinical assessment and diagnosis, RGM was administered for a period of 90 days with 15 days drug holiday after 45 days of treatment. Later the treatment outcomes were measured and the patient is followed up for 6 months. This study reveals the outcome of the treatment of Karuppai Naarthasai Kattigal with RGM and the prognosis of the patient is calculated with, symptomatic improvement, reduction in size of fibroid and changes in pictorial blood assessment chart score from baseline visit to final visit and reduction in clinical symptoms of the patient by using uterine fibroid quality-of-life questionnaire, and the data were recorded.

Keywords: Case report, Karuppai Naarthasai Kattigal, RGM, Siddha, uterine fibroids


How to cite this article:
Swapna AJ, Lekha GS, Rajkumar S. Case report on treatment of Karuppai Naarthasai Kattigal (uterine fibroids) with Rasagandhi Mezhugu. J Res Siddha Med 2022;5:35-40

How to cite this URL:
Swapna AJ, Lekha GS, Rajkumar S. Case report on treatment of Karuppai Naarthasai Kattigal (uterine fibroids) with Rasagandhi Mezhugu. J Res Siddha Med [serial online] 2022 [cited 2023 Jun 3];5:35-40. Available from: http://www.jrsm.in/text.asp?2022/5/1/35/374335


  Introduction Top


Apart from modern concepts about uterine fibroids, Siddha system of medicine closely refers fibroid uterus as Karppa Vippuruthi, described in Yugi Vaidya Chinthamani.[1]Vippuruthi is commonly described as excessive or abnormal growth.[2] To be more specific, Vippuruthi pertaining to the uterus is known as Karppa Vippuruthi.[1] Abdominal swelling, pain, heaviness in the lower abdomen, menstrual disturbances, weakness, emaciation, loss of appetite, increased thirst, white discharge, and dysuria are mentioned as symptoms of Karppa Vippuruthi in Sri Lankan Tamil literatures.[2] Lower abdomen distension, pain, dryness, emaciation, fever, headache, pricking pain all over the body, and poor stamina are mentioned as symptoms of Karppa Vippuruthi in Agathiyar 2000.[3] Premenstrual abdomen pain that gets relieved after menstruation, pain in the thigh, headache, infertility, emaciation, hard lump-like stools, and constipation are elaborated as symptoms of Karppa Vippuruthi in Aathma Ratchamirtham Ennum Vaithiya Sangraham.[4] Abdomen bloating, lower abdomen pain, dryness of skin, constipation, headache, stasis of blood in uterus, and abdomen fullness are mentioned by Kannusamy Pillai.[5] Separate hard lumps, pus and blood-stained stools, emaciation, hot flashes, and uterine mass are indicated as symptoms of Karppa Vippuruthi by Agathiyar.[6] Along with the symptoms, the reasons behind the fibroids are mentioned by Yugimuni as improper dietary habits such as excessive intake of large fishes in diet.[7] A literary review reveals that a classical Siddha formulation—Rasaganthi Mezhugu (RGM)—, mentioned in Siddha literature Pulippani Vaithiyam-500, is indicated for the management of Vippuruthi.[8] The safety and efficacy of Rasagandhi Mezhugu (RGM) are studied in various research journals, and the drug is found to be safe and effective in treating uterine fibroids.[9],[10]

As the cases of hysterectomy due to uterine fibroids are increasing nowadays, this study would support in providing an alternative and a noninvasive option in the treatment of uterine fibroids through Siddha system of medicine. This study focuses on a case report of a patient with Karuppai Naarthasai Kattigal (uterine fibroids) treated with a classical Siddha drug RGM for a period of 90 days, after receiving the informed consent, and the outcome was measured.

This study was planned to observe the effect of RGM in treating Karuppai Naarthasai Kattigal (uterine fibroids) with a case study and to record the outcome from baseline visit to follow-up, ensuring the safety of the drug.


  Case presentation Top


Patient details

A 40-year-old female patient with symptoms of heavy uterine bleeding and low back pain during menstrual time, increased frequency to urinate, abdomen bloating for 6 months, and intermenstrual bleeding for 2 years reported to the outpatient department of Siddha Regional Research Institute, Thiruvananthapuram, Kerala, India. The patient did not have any past illnesses such as type 2 diabetes and systemic hypertension. Past history of similar illnesses in her family was not found. The patient was psychologically stable. After ensuring her vital signs to be normal, the patient was included in the study after informed consent. Fulfilling a study period of 90 days of treatment (excluding drug holiday of 15 days after the 45-day treatment), the expected outcomes were measured and the patient is followed up for a period of 6 months.

Assessment tools

Siddha assessment of Thaegi was Iyaazhal and Envagai Thervugal revealed Valiazhal Naadi, which supports the symptoms of the patient such as abdominal discomfort and bloatedness.[11] Apart from routine blood investigations, PAP smear analysis was also performed before treatment to exclude cervical malignancy.[12] Screening through ultrasonogram (USG) using Vinno E 10 Value color Doppler was used in imaging the presence of fibroid and in assessing the changes in the size of fibroid. The lower abdominal pain was assessed by visual pain analog scale (VAS), and the amount of bleeding was assessed through a pictorial blood assessment chart (PBAC). ROME criteria II was used to assess pressure symptoms such as constipation and frequent urination, and the outcome was assessed using the uterine fibroid quality-of-life questionnaire (UF-QOL) [Table 1] and [Table 2].
Table 1: QOL (quality of life)—before treatment

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Table 2: QOL (quality of life)—after treatment

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Clinical findings

A female patient with complaints of excessive intermenstrual bleeding, abdominal cramps, mild constipation, and severe low back pain especially during menstrual cycle was subjected to abdominal Examination and revealed tenderness in hypogastric region. Abdominal examination revealed tenderness in hypogastric region. She had a heavy menstrual bleed and it was recorded through PBAC score of 140. The patient was screened on 2nd March 2021. Her vital signs were normal. An intramural fibroid measuring 1.5 × 1.1 × 1.6 cm (vol 1.5 cm3) at fundal region and a small intramural calcification measuring 0.9 × 0.5 cm in anterior wall were observed in the USG.

Therapeutic intervention

Preliminary laboratory investigations, including liver function test (LFT) and renal function test (RFT), were found to be in a normal range. Clinical assessment through Siddha parameters and PAP smear analysis was conducted, and treatment was started from March 8, 2021 onward. The trial drug RGM500 mg with palm jaggery of 2.5 g as adjuvant was administered to the patient for a period of 90 days, twice a day after food with a 15-day drug interval midway. A strict diet regimen to avoid nonvegetarian diet, intake of 8–10 glasses of water per day, and intake of 250 mL of buttermilk twice a day was advised. After the drug holiday, her LFT and RFT were checked to be normal to ensure the safety of the drug. After 90 days of drug intake, she had lower abdominal pain relief and menstrual bleeding was normal (PBAC score 108). USG on July 15, 2021, revealed that the intramural fibroid had a marked decrease in size and the volume reduced from 1.2 × 1.1 × 1.1 cm (1.5 cm3) to 1.5 × 1.1 × 1.6 cm (0.8 cm3) [Table 3].
Table 3: Changes in size and volume of the fibroid

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On the follow-up after a period of 6 months on December 20, 2021, USG whole abdomen revealed that the intramural fibroid had reduction in size, i.e., 1 × 1.1 × 1.1 cm (vol 0.7 cm3) [Table 3] compared to the volume before the treatment. Symptomatically patient had regular menstrual cycles without any sort of abdominal cramps and low backache. Pressure symptoms such as frequent urination were relieved. The prognosis was evaluated through self-administered questionnaires on UF-QOL [Table 1] and [Table 2], Siddha assessment [Table 4] (before and after treatment), and the data were documented. No adverse drug event was reported, and there were no changes in LFT and RFT before and after the treatment and follow-up throughout the study period.
Table 4: Siddha assessment

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Lab investigation

Every time on her visit, on the 15th day, the clinical assessment form was recorded. Likewise on the 30th day and the 45th day the clinical assessment was recorded. After the drug holiday of 15 days, after the 45th day, that is, on the 60th day, LFT and RFT were recorded and found to be in normal range. Clinical assessment was recorded on the 75th, 90th, and 105th day; USG and laboratory investigation were taken after completion of the treatment. There was a follow-up of the patient without trial medicine for 6 months. All the laboratory investigations and USG were done in the ninth month, that is, completion of the study.

Data collection

After getting the informed consent from the patient, data such as history proforma, Siddha assessment, and clinical assessment forms are filled along with self-administered questionnaires on UF-QOL (before treatment, after treatment, third month of follow-up and after sixth month of follow-up). The PBAC score [Table 5] was used to assess menstrual bleeding during baseline visit to final visit during treatment. The lower abdominal pain was assessed by VAS [Table 6]. Clinical assessment was recorded in every 15 days; USG and laboratory investigations were recorded before treatment, at the end of third month, and at the end of ninth month after follow-up. This case report was drafted based on Standard Reporting CARE guidelines (case reporting).
Table 5: Reduction in PBAC score

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Table 6: Reduction in VAS score

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  Outcome of the study Top


In this study, we have observed and documented the effect of treating Karuppai Naarthasai Kattigal (uterine fibroids) with RGM. Our results suggested that the patient undergone the study had a marked reduction in the size and volume of the fibroid from 1.5 × 1.1 × 1.6 cm (vol 1.5 cm3) to 1 × 1.1 × 1.1 cm (vol 0.7 cm3) as mentioned in [Table 3] and qualitatively represented in [Chart 1]. The small intramural calcification of 0.9 × 0.8 cm did not reveal any changes throughout the study. Moreover, Siddha assessment reveals that the patient had a relief from increased frequency of micturition, indicating reduction in pressure symptoms and Neerkuri Neikuri was Azhal Neer (spread slowly in the shape of a ring) after treatment indicating improvement in patient’s health [Table 4].[13] Renal parameters and liver function tests were under normal range before and after treatment. PAP smear analysis was conducted before the revealed exclusion of cervical malignancy. Moreover, the patient had relief from abdominal cramps, low backache, and it was measured qualitatively through VAS [Table 6]. She had no intermenstrual bleeding, no fluctuations in her periods, and a marked reduction in heavy menstrual bleeding measured quantitatively through PBAC score during the treatment [Table 5], [Chart 2].
Chart 1: Reduction in size and volume of fibroid

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Chart 2: Improvement in PBAC score

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[Chart 1] shows that there was a marked reduction in the size and volume of the fibroid which was 1.5 cm3 before treatment and 0.8 cm3 after treatment. [Chart 2] reveals a marked improvement in PBAC score from 140 before treatment and 108 after treatment. Quality-of-life (QOL) assessment was satisfactory after the treatment [Table 1] and [Table 2], and the patient was also symptomatically improved. From Siddha assessment parameters [Table 4], clinical findings, and imaging through USG, we could conclude that the patient has improved after treatment with RGM for a period of 90 days and a follow-up after 6 months.

Adverse events

Nil.

Informed consent

Informed consent was obtained from the patient.


  Discussion Top


The classical Siddha drug RGM had a potential action in treating Karuppai Naarthasai Kattigal (uterine fibroids) with reduction of the fibroid as well as improvement in QOL of the patient. Throughout the course of the treatment, patient had no adverse effects or unanticipated events, and the blood investigations revealed the drug safety. The study has limitations such as it is not suitable for fibroids more than 8 cm in size, as well as in patients who had a previous surgical intervention for fibroid uterus. Patients with metabolic disorders are also excluded to avoid drug interactions. Patients above 45 years are not suitable for the study to avoid the effects of menopause. Thus, RGM mentioned in Siddha literature Pulippani Vaithiyam-500 indicated for the management of Karuppai Naarthasai Kattigal (uterine fibroids) proves to be safe and effective.

The study resulted in marked reduction in the size and volume of fibroid, reduction in PBAC score, and relief in clinical symptoms from baseline visit to follow-up. Moreover, assessment of the UF-QOL was achieved through the treatment course. This case study will be helpful and provide an effective alternative method in treating uterine fibroids, considering the limitations of the study.

Financial support and sponsorship

This study was funded by Central Council for Research in Siddha through IMR scheme, Ministry of Ayush, Government of India.

Conflicts of Interest

There are no conflicts of interest.





 
  References Top

1.
Thyagarajan . Yugi Vaidya Chinthamani, Part 1. Chennai: Gandheepam printers; 1976. p. 442-3.  Back to cited text no. 1
    
2.
Sambasivampillai TV. Dictionary of Medicine, Chemistry, Botany and Allied Sciences. Vol 5. Chennai: Indian Medicine and Homeopathy Department; 1994. p. 130.  Back to cited text no. 2
    
3.
Venkatarajan . Agathiyar 2000, Part 2. Tanjore: Vetrivel press; 1968. p. 13.  Back to cited text no. 3
    
4.
Kandasamy M. Aathama Ratchamirtham Ennum Vaithiya Sangraham. Chennai: Shenbaga Publishers; 2011. p. 54.  Back to cited text no. 4
    
5.
Shanmugaraja S. Siddha Maruthuva Mahapetriyalum Magalir Maruthuvamum. Chennai: Bharathi Publishers; 2007. p. 59-62.  Back to cited text no. 5
    
6.
Kannusamy Pillai. Sikitcharathnadeepam—Vaithiya Chinthamani, Part 2. Chennai: Thirumagalvilasa Publishers; 1927. p. 142-3.  Back to cited text no. 6
    
7.
Kuppusamy M. Siddha Vaidya Thiratu. Chennai: Directorate of Indian System of Medicine; 1998. p. 174-7.  Back to cited text no. 7
    
8.
Pulipani, Pulippani Vaithiyam-500. 1st ed. Chennai: Chennai Malar Mahal vilasa Printers; 1999. p. 72-3.  Back to cited text no. 8
    
9.
Shyamala R, Vijaya Kumar V, Ponmuthu Rani C, Gopakumar K, Ramaswamy RS. Management of fibroid uterus with a traditional Siddha formulation—A review. Int J Multidiscip Health Sci 2015; I: 1-14.  Back to cited text no. 9
    
10.
Sheeja T, et al. Toxicity studies of Siddha medicine—Rasaganthi Mezhugu. Open Toxicol J 2010;4:43-50.  Back to cited text no. 10
    
11.
Shanmugavelu M. Noinaadal Noimudhal Naadal Thirattu, Part-II (Tamil). 4th ed. Chennai: Indian Medicine and Homeopathy Department; 2003. p. 182, 245-69.  Back to cited text no. 11
    
12.
Harsh M. Textbook of Pathology. 6th ed. Jaypee Brothers Medical Publishers (P) Ltd; 2010. p. 268-6.  Back to cited text no. 12
    
13.
Shanmugavelu M. Noinaadal Noimudhal Naadal Thirattu. Part-II (Tamil). 4th ed. Chennai: Directorate of Indian Medicine and Homeopathy; 2003. p. 300.  Back to cited text no. 13
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

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



 

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Abstract
Introduction
Case presentation
Outcome of the study
Discussion
References
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