E-ISSN:2456-3110

Research Article

Shatavari Guggulu

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 9 September
Publisherwww.maharshicharaka.in

A randomized controlled clinical study to evaluate the efficacy of Shatavari Guggulu in Janusandhigata Vata

Swathilakshmi Ps1*, Shetty S2, Babu Paul K3
DOI:10.21760/jaims.8.9.4

1* Swathilakshmi Ps, Final Year Post Graduate Scholar, Department Of Pg Studies In Kayachikitsa, Alvas Ayurveda Medical College, Moodubidire, Karnataka, India.

2 Susheel Shetty, Professor and Head, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India.

3 Babu Paul K, Assistant Professor, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India.

Background: Sandhigata Vata is one of the Vatavyadhis named based on the Sthaanavaishishtyatha of vitiated Vata. It mainly presents with Sandhishoola and Shopha further leading to difficulty in movements. Knee Osteoarthritis is the most common type of arthritis, which is a major cause of disability which reduces the quality of life. Osteoarthritis principally targets the knee joint, hip joint and certain small joints. Methodology: 60 patients fulfilling the diagnostic and inclusion criteria were selected for a single blind randomized controlled clinical study. They were randomly allocated into 2 equal groups Group A and Group B. Subjects of Group A received Shatavari Guggulu in a dosage of two tablets three times a day after food with Sukoshna Jala for 30 days and Group B subjects received Trayodashanga Guggulu with same dose and duration. Assessment was done before treatment,16th day, 31st day (After treatment) and follow up on 46th day. Result: When both groups were compared clinically, both showed effective changes in most of the parameters. The statistical analysis of within the group comparison showed statistically significant results in both groups for all parameters except in Atopa. When statistical comparison was done between the two groups, no significant difference was found. Conclusion: Both Shatavari Guggulu and Trayodashanga Guggulu showed statistical significant effect in all parameters except in Atopa. On statistical comparison between the two groups there is no significant difference in the effect of both Shatavari Guggulu and Trayodashanga Guggulu. Thus, H1 is rejected and H0 is accepted.

Keywords: Janusandhigata Vata, OA Knee, Shatavari Guggulu, Trayodashanga Guggulu, Vatavyadhi.

Corresponding Author How to Cite this Article To Browse
Swathilakshmi Ps, Final Year Post Graduate Scholar, Department Of Pg Studies In Kayachikitsa, Alvas Ayurveda Medical College, Moodubidire, Karnataka, India.
Email: 		Swathilakshmi Ps, Shetty S, Babu Paul K, A randomized controlled clinical study to evaluate the efficacy of Shatavari Guggulu in Janusandhigata Vata. J Ayu Int Med Sci. 2023;8(9):22-27.
Available From
https://jaims.in/jaims/article/view/2763

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-08-28 2023-09-05 2023-09-11 2023-09-17 2023-09-21
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared Nil Yes 22.22

© 2023by Ps S, Shetty S, K Band Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

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Swathilakshmi PS et al. Efficacy of Shatavari Guggulu in Janusandhigata Vata

Introduction

Sandhigata Vata (Osteoarthritis) is a clinical condition that comes under the heading of Vatavyadhi. In normalcy Vata Dosha governs the remaining Doshas and the whole body,[1] but in morbid state it can produce pathological conditions like Vatavyadhi. The presentation of Vatavyadhi varies depending upon factors like Sthana (Site) or structures involved.[2]

Sandhigata Vata is one of the Vatavyadhi named based on the Sthaanavaishishtyata of vitiated Vata.[3] It mainly presents with Sandhi Shoola (Joint Pain) and Shopha (Swelling) further leading to difficulty in movements.[4]

The signs and symptoms of osteoarthritis of knee joint resembles Lakshana of Janusandhigata Vata. Osteoarthritis is by far the most common form of arthritis. It shows a strong association with ageing and is a major cause of pain and disability in elderly.

Osteoarthritis principally targets the knee joint, hip joint and certain small joints. There is a steady rise in prevalence from age 30 such that by 65, 80% of people have radiographic evidence of OA, though only 25-30% are symptomatic.[5] Due to the increased prevalence of this disorder and the disabilities produced, it has become a major problem and burden over the society, indirectly reducing the working potential which results into dependency.

Management of Sandhigata Vata includes a judicious combination of Bahya Chikitsa (External Medication) and Abhyantara Chikitsa (Internal Medication). Abhyanga (Massage), Upanaha (Type of fomentation), Agnikarma (Therapeutic heat burn), Bandhana (Bandage)[6] etc. are the Bahya Chikitsa and Gokshuradi Guggulu,[7] Yogaraja Guggulu,[8] Maharasnadi Kwatha[9] are some of the Abhyanthara Chikitsa. In Sandhigata Vata, along with morbid Vata Dosha, there can be morbid Kapha Dosha association also, which can be inferred from Sandhi Stabdhata. So morbid Kapha also to be tackled during the course of treatment if there is morbidity of Kapha Dosha. In Modern science, weight loss, exercise and analgesic treatment has been advised for OA knee.[10]

Shatavari Guggul[11] mentioned in Rasaratna Samucchaya was taken as trial drug for proving

its efficacy in the management of Janusandhigata Vata. It mainly contains drugs having Vatahara, Shoolahara, Agni Deepana properties. Trayodashanga Guggulu[12] was taken as standard drug.

Hence with the present clinical study Shatavari Guggulu and Trayodashanga Guggulu were taken, and results were compared for checking the better efficacy in Janusandhigata Vata.

Aims and Objectives

1. To evaluate the therapeutic effect of Shatavari Guggulu in the management of Janusandhigata Vata.
2. To compare the therapeutic effect of Shatavari Guggulu and Trayodashanga Guggulu in the management of Janusandhigata Vata.

Materials and Methods

Source of sample

Patients of either sex attending OPD of Alva’s Ayurveda Medical College & Hospital, Moodubidire and from other available sources who were diagnosed with Janusandhigata Vata were selected for study. Details of the patients were documented in a case proforma.

Study design

Randomised controlled clinical study with single blinding.

Methods of collection of data

Selection: Incidental selection was done irrespective of gender, religion, occupation, marital status, educational status, socio-economic status, those fulfilling the diagnostic criteria and inclusion criteria were selected.

Allocation: Random allocation
Method of sampling: Lottery method
Groups: 2 groups
Group A - Shatavari Guggulu
Group B - Trayodashanga Guggulu
Sample size: 30 patients in each group
Total sample size: 60 patients minimum

Diagnostic criteria

Patients were diagnosed based on Lakshanas of Janusandhigatha Vata such as:

  • Shotha - Oedema of the joints.

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  • Shoola - Pain in the joints.
  • Prasarana Aakunchana Vedana - Presence of pain during flexion and extension of joint.

Inclusion criteria

1. Patients showing the classical Lakshana of Janusandhigata Vata like Sandhi Shotha, Sandhi Shoola and Prasarana Akunchana Vedana; with or 2. without Atopa (Crepitus), Stambha (Stiffness).
3. Patients diagnosed with Janusandhigata Vata.
4. Patients of either sex between 30 to 70 years of age.
5 .Subjects who are willing to participate and sign in the informed consent form.

Exclusion criteria

1. Subjects suffering from diseases like Amavata (Rheumatoid arthritis), Vatarakta (Gouty arthritis) or any other systemic disorders.
2. Secondary Osteoarthritis of Knee.
3. Subjects with deformities like Genu varum and Genu valgum.
4. Subjects who require surgical interventions.
5. Subjects who are under Intra-Articular injection of Corticosteroid 3 months preceding enrolment.
6. Pregnant women and Lactating mother.

Subjective parameters

  • Janu Sandhi Shoola
  • Janu Sandhi Stambha

Objective parameters

  • Janu Sandhi Shotha
  • Janu Sandhi Atopa
  • Janu Sandhi Prasarana and Akunchana Vedana - measured using Goniometer and expressed in degrees.
  • Tenderness
  • Visual Analogue Scale (VAS)
  • WOMAC OA Index

Observation period

Patients were assessed clinically on day 0, on 16th day and on 31st day of clinical study.

Follow up was done after 15 days of the treatment i.e., on 46th day.

Ingredients of Shatavari Guggulu: Shatavari, Guduchi, Gandhaprasarani, Gokshura, Pippali, Shatahva, Deepyaka, Rasna, Ashwagandha, Padmaka, Kachura, Nagara, Guggulu and Ghrita.

Ingredients of Trayodashanga Guggulu: Abha, Ashwagandha, Hapusha, Guduchi, Gokshura, Vriddhadaru, Shatavari, Shati, Rasna, Shatapushpa, Yavani, Nagara, Guggulu and Ghrita.

Intervention

Table 1: Intervention given for both the groups

GroupDoseTime of administrationDurationAnupana
Group A - Shatavari Guggulu500 mg,2 TabletsThrice daily, After food30 daysUshnodaka (Warm water)
Group B -Trayodashanga Guggulu500 mg,2 TabletsThrice daily, After food30 daysUshnodaka 

Observations and Results

Table 2: Observation of 60 patients

CharacteristicsPredominancePercentage
Age50-59 years36.6%
GenderFemale53.33%
OccupationHousewives35%
Family HistoryNegative83.33%
DietVegetarians51.66%
PrakritiVata Kapha48.33%
SatwaPravara51.66%
Jarana ShaktiPravara68.33%
Vyayama ShaktiMadhyama63.33%
BMINormal61.66%
Onset of PainGradual100%
Character of PainDull Aching68.33%
Course of PainIntermittent75%

Statistical Analysis

Statistical software used in the study was Sigma Stat version 3.1.RM Anova on Ranks and One way RM Anova was performed to prove the effectiveness of the medicine before and after trial. Mann-Whitney Rank Sum Test and Unpaired t-Test was performed for comparative analysis of the overall effect of the treatments in both the groups.

After the observations when results were statically analyzed by RM Anova on Ranks, in Group-A there was significant effect in all parameters except Stambha, Atopa and Tenderness. In terms of percentage relief, there was 55.21% relief in Janusandhi Shoola, 50% relief in Janusandhi Stambha, 86.7% relief in Shotha, 6% improvement in range of motion, no relief in Atopa


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, 54.04% reduction in VAS and 29.3% improvement in WOMAC OA index.

Table 3: Effectiveness of the medicine before and after trial

Assessment CriteriaGroupMean ValueRM Anova On Ranks
BTATQ ValueP<0.05
Janusandhi ShoolaGroup A2.23318.839Yes
Group B2.0670.9338.768Yes
Janusandhi StambhaGroup A0.06670.03330.283No
Group B0.2330.03331.697No
Janusandhi ShothaGroup A10.1337.354Yes
Group B10.3335.657Yes
Prasarana Akunchana VedanaGroup A125132.58.556Yes
Group B125.833131.8338.273Yes
AtopaGroup A0.8670.8670No
Group B0.9330.9330No
TendernessGroup A0.100.849No
Group B0.20.03331.414No
VASGroup A4.9332.26710.253Yes
Group B52.210.536Yes
WOMACGroup A38.126.9339.263Yes
Group B37.26726.1679.758Yes

In Group B also there was significant effect in all parameters except Stambha, Atopa and Tenderness. In terms of percentage relief, there was 54.7% relief in Janusandhi Shoola, 85% relief in Janusandhi Stambha, 66.7% relief in Shotha, 4% improvement in range of motion, no relief in Atopa, 56% reduction in VAS and 29.7% improvement in WOMAC OA index.

Table 4: Comparative analysis of overall effect of the treatments in both the groups

Assessment criteria Median Value (BT-AT) Mann Whitney Test Remark
Group AGroup BT ValueP Value
Janusandhi Shoola119620.490Non-Significant
Janusandhi Stambha008400.268Non-Significant
Janusandhi Shotha1110050.184Non-Significant
Prasarana Akunchana Vedana558520.355Non-Significant
Atopa009150.994Non-Significant
Tenderness008850.661Non-Significant
VAS338620.437Non-Significant
WOMAC1210930.50.824Non-Significant

On comparing the effect of Shatavari Guggulu and Trayodashanga Guggulu in all the parameters suggest that there is no significant difference between both the groups

on comparing the difference of treatment of all observation time points with reference to BT, D16 and AT which suggests that both the drugs are having equal effect in the management of Janusandhigata Vata.

Discussion

As Janusandhigata Vata is a Vatavyadhi which usually occurs in Vriddhavastha we need a formulation which should contain Vatahara, Balya and Rasayana Guna.

Probable mode of action of Shatavari Guggulu

Shatavari and Gokshura are having Madhura Rasa, Guduchi, Gandhaprasarani, Padmaka, Rasna are having Tikta Kashaya Rasa, Guggulu, Ashwagandha, Deepyaka, Shatahva are having Katu Tikta Rasa and Naagara, Pippali has Katu Rasa. Most of the drugs are having Katu Tikta Kashaya Rasa which help to remove the Kapha which does the Avarana of Vata leading to Vataprakopa and Stambha in the Sandhi Pradesha. When the Avarana gets cleared, automatically Vata will come into normalcy thereby reducing the symptoms.

Prakupita Vata is the main culprit in Sandhigata Vata. As most of the drugs are having Vatahara effect it will help for the reduction of symptoms.

Majority of the drugs are having Ushnaveerya which helps to pacify the Vata dosha and to remove the Srotoavarodha.

Shatavari, Guduchi, Gokshura, Pippali, Naagara are having Madhura Vipaka. Madhura Vipaka Dravyas will pacify the Prakupita Vata.

Due to Vataprakopa there will be Agnivaishamyata which leads to improper formation of Annarasa thereby forming Uttarottara Dhatukshaya. Deepaneeya Dravyas present in this formulation like Guduchi, Gokshura, Pippali, Shatahva, deepyaka, Shunti will correct the Agni in turn leading to the proper formation of Dhatu.[13]

Probable mode of action of Trayodashanga Guggulu

Vata and Kapha are the main culprit in Sandhigata Vata. Most of the drugs in the formulation are having Vata Kaphahara, Ushna Veerya, Madhura Vipaka, Deepana and Rasayana property which helps to the Samprapti Vighatana of the disease.

Guggulu Kalpana


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is a very important formulation where the drug augments the formulations with the other drugs in it without losing its potency and it acts effectively in treating the disease.

The Aushadha Sevana Kala (Time of administration of medicine) is Adhobhakta i.e., Bheshaja (Medicine) is administered after meals. As per the classics Adhobhakta Aushada Kala is indicated in Vyanavayu Vikriti and Udanavayu Vikriti. As in Janusandhigata Vata both the Shleshaka Kapha and Vyana Vayu are affected, this Aushadha Kala is opted.

Conclusion

When comparing both the drugs clinically, both the drugs showed effective changes. On statistical comparison within the groups, both the groups showed significant effect (P<0.05) Significant action of the drugs was not shown during the initial 15 days of treatment in all the parameters except VAS and WOMAC. After treatment there was significant effect on all the parameters except Atopa, where statistically insignificant effect was seen. The effect of the drugs was maintained even after the treatment till the period of follow up. On comparing between two groups, there was no statistically significant difference in the effect of treatment with P >0.05. Hence null hypothesis(H0) is accepted.

H0 - There is no statistically significant difference in the effect of Shatavari Guggulu and Trayodashanga Guggulu in Janusandhigata Vata.

Acknowledgement

I would like to express my gratitude to my institution and hospital who gave me the possibility to complete this project. Also, I take this opportunity to express my gratitude to mu Guide and Co-guide for their valuable guidance.

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12. Chakrapanidatta, Chakradatta


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