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Clinical Trials/CTRI/2023/09/057542
CTRI/2023/09/057542RecruitingPhase 3

Randomised controlled clinical trial of efficacy of Munditika churna and Haritaki churna in the management of Vatarakta (gout)

Pathan Md Junaid Naim Khan1 site in 1 country160 target enrollmentStarted: September 25, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Improvement in vatarakta sign & symptoms

Study Overview

Brief Summary

Vatrakta is one of the Vatavyadhis, a disease where both Vata and Rakta are afflicted by distinct etiological factors. There are 02 types of Vatarakta i.e., Uttana Vatarakta produces symptoms like itching, burning sensation, pain, brown-blackish discolouration of skin. While, Gambhira Vatarakta produces symptoms like swelling, hardness, tenderness, burning sensation, pain. Sometimes numbness is also present. Vatarakta can be corelated with Gout. Gout is the most common inflammatory arthritis in men and in older women. Gout is the most common form of inflammatory arthritis. As the level of uric acid [in men (≤ 7 mg/dl) and women (≤ 6 mg/dl)] crosses its saturation thresholds in physiological fluids urate crystals precipitation starts in the joints leading to gout. In Ayurveda Vatarakta has been described in detail with different useful treatment modalities. One of such treatment for Vatarakta is classicaly recommended in Bhaishajya ratnavali is Munditika churna & Haritaki churna. so, this RCT is planned to evaluate efficacy of both these churna (Munditika & Haritaki churna). The main outcome of this trial is to evaluate improvement in symptoms viz. 1. Shotha (Swelling)2. Kathinya (Stiffness & Hardness)3. Vedanadhikya (Severe pain)4. Daha (Burning sensation)5. Toda (Pricking pain)6. Shyavata & tamrata (Blackish or Coppery joint discolouration)7. Sphurana (Twitching sensation) and changes in changes in sr. Uric acid levels.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • •Participants having classical sign & symptoms of Vatarakta like.
  • •Shotha (Swelling)
  • •Kathinya (Stiffness & Hardness)
  • •Vedanadhikya (Severe pain)
  • •Daha (Burning sensation)
  • •Toda (Pricking pain)
  • •Shyavata & tamrata (Blackish or Coppery)
  • •Sphurana (Twitching sensation)
  • •Participants having age group between 18 years to 60 years
  • •Participants having Serum Uric acid level > 7 mg/dl in Males & >6 mg/dl in Females
  • •Participants will be selected irrespective Gender, Religion, Socio-Economic status.

Exclusion Criteria

  • •Participants having complications like Paka, Khanja, Pangulya and Sandhi vakrata will be excluded.
  • •Alcohol and drug abusers, Pregnant and lactating women
  • •Symptomatic participants with clinical evidence of Kidney failure
  • •k/c/o Malignancy, poorly controlled DM, HTN
  • •Participants having other acute or complicated systemic disease which require long term drug treatment.

Outcomes

Primary Outcomes

Improvement in vatarakta sign & symptoms

Time Frame: 15th, 30th, 45th day

Secondary Outcomes

  • decrease in Hyperuricemia (Sr. Uric acid) level(45th day)

Investigators

Sponsor
Pathan Md Junaid Naim Khan
Sponsor Class
Other [self]

Study Sites (1)

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