To compare the clinical efficacy of Nili (Indigofera tinctoria Linn.) Panchanga Churna and its hydroalcoholic extract on Vatarakta.

Phase 2/3

Completed

Brief Summary: Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/81/2023, Date-24/01/2023) and registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056496, [Registered on 14/08/2023]. Study type was randomized single-blind, parallel arm clinical trial. 36 patients were enrolled and divided into two groups (i.e., Group A â€“*Nili Panchanga Churna*, Group B â€“ Hydroalcoholic extract of *Nili* *Panchanga*) 18 patients in each group were allocated. Total 33 patients (i.e., 15 patients in group A and 18 patients in Group B) completed the study. All individual of two groups A and B were having significant difference in percentage in *Vatarakta*. In Group A- *Sandhi Pradeshe Shoola* (65.56%), *Sphurana-Ayama* (33.33%), *Rakta/Tamra/Shyava Twak* (26.67%), *Sparshasahata* (20%), *Sandhi Pradeshe Daha* (37.78%), *Kandu* (26.67%), *Sandhi Pradeshe Shotha* (54.44%) and *Supti* (26.67%) results were observed. In Group B- *Sandhi Pradeshe Shoola* (40.74%), *Sphurana-Ayama* (11.11%), *Rakta/Tamra/Shyava Twak* (27.78%), *Sparshasahata* (12.96%), *Sandhi Pradeshe Daha* (28.70%), *Kandu* (11.11%), *Sandhi Pradeshe Shotha* (23.15%) and *Supti* (12.96%) results were observed. Significant difference observed between group A and B.

Recruitment & Eligibility

Inclusion Criteria

1)Sandhi Pradeshe Shoola/ Nistoda/ Bheda (Pain/ pricking / tearing pain in joint) 2)Sphurana-Ayama (Twitching sensation.
Stretching) 3)Rakta/ Tamra / Shyava Twak (Reddish/copper/ bluish discolouration of skin) 4)Sparshasahata (Tenderness) 5)Sandhi Pradeshe Daha (Burning sensation over joint area) 6)Kandu (Itching) 7)Sandhi Pradeshe Shotha (Swelling over joint area) 8)Ruk Bhutva Bhutva (Episodic pain) 9)Atisweda/ Asweda (Hydrosis/anhydrosis) 10)Supti (Numbness) 11)Alasya (Lethargy) 12)Sadanam (fatigue) 13)Pidikodgam/ Mandalotpatti (Apperance of papules/ patches) 14)Kshate ati ruka (Severe pain on injury).

Exclusion Criteria

Age less than 18yrs and greater than 65yrs.
Pregnant women and lactating mother.
Patients with the Updrava of Vatarakta.
Patients with other Systemic diseases such as Diabetes Mellitus, Hypertension, Cardiac anomaly, Renal & hepatic disorders.

Primary Outcome Measures

Name	Time	Method
Definite change in serum uric acid level	4 weeks

Secondary Outcome Measures

Name	Time	Method
1)Sandhi Pradeshe Shoola/ Nistoda/ Bheda (Pain/ pricking / tearing pain in joint)	2)Rakta/ Tamra / Shyava Twak (Reddish/copper/ bluish discolouration of skin)

Locations (1): Government Ayurved Hospital, Vadodara
🇮🇳
Vadodara, GUJARAT, India
Government Ayurved Hospital, Vadodara
🇮🇳Vadodara, GUJARAT, India
Kunjal Patel
Principal investigator
8849199795
nita.kunjal@gmail.com